A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease (BEconneCTD-ILD)

March 2, 2026 updated by: GlaxoSmithKline

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alejandro Brigante
      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • carolina mariasch
      • Buenos Aires, Argentina, C1128AAF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Maria Malet Ruiz
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Jose Lopez Meiller
      • Córdoba, Argentina, X5000AAW
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mercedes Cordoba
      • Mendoza, Argentina, 5500
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carlos Martin Elias Rein
        • Contact:
        • Contact:
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodolfo Navarrete
      • San Miguel de Tucumán, Argentina, T4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Raul Sueldo
      • Santa Fe, Argentina, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nadia Benzaquen
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vidya Limaye
      • Woodville, South Australia, Australia, 5011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maureen Rischmueller
    • Western Australia
      • Spearwood, Western Australia, Australia, 6163
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Bremner
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Antoine Froidure
        • Contact:
        • Contact:
      • Brussels, Belgium, 1090
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karin Melsens
      • Liège, Belgium, 4000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Julien Guiot
        • Contact:
        • Contact:
      • Namur, Belgium
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Caroline Dahlqvist
  • Brazil
      • Barra Mansa, Brazil, 27323240
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gilmar Alves Zonzin
      • Juiz de Fora, Brazil, 36010-570
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viviane Souza
      • Porto Alegre, Brazil, 90020-090
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adalberto Rubin
      • Porto Alegre, Brazil, 90480000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mauro Keiserman
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe Colares
      • São Paulo, Brazil, 04004-030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruno Baldi
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Paula Assad
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Hirsch
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrice Gauthier
  • China
      • Beijing, China, 100020
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Juan Meng
        • Contact:
        • Contact:
      • Beijing, China, 100730
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mengtao Li
      • Chengdu, China, 610072
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • wubin long
      • Guangzhou, China, 510630
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yunfeng Pan
      • Guangzhou, China, 510100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yang Li
      • Hangzhou, China, 310052
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jing Xue
      • Hangzhou, China, 310003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Lin
      • Mianyang, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jing Yang
      • Nanjing, China, 210029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wenfeng Tan
      • Nanjing, China, 210008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lingyun Sun
        • Contact:
        • Contact:
      • Nanning, China, 530000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • jinying lin
      • Shanghai, China, 200040
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Weiguo Wan
        • Contact:
        • Contact:
      • Shanghai, China, 200001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • LI TING
      • Shenyang, China, 110001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rong Zhang
        • Contact:
        • Contact:
      • Suzhou, China
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jian wu
        • Contact:
        • Contact:
      • Tianjin, China, 300052
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Wei Wei
        • Contact:
        • Contact:
      • Zhuzhou, China, 412007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jingyang Li
        • Contact:
        • Contact:
  • France
      • Angers, France, 49933
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frédéric Gagnadoux
        • Contact:
        • Contact:
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gaétane Nocturne
      • Lille, France, 59037
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • eric hachulla
      • Pessac, France, 33604
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-François Viallard
      • Rouen, France, 76000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mathieu Salaun
      • Toulouse, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gregoire Prevot
        • Contact:
        • Contact:
  • Germany
      • Essen, Germany, 45293
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Bonella
      • Mainz, Germany, 55131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Kreuter
      • Minden, Germany, 32429
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gunter Assmann
      • Würzburg, Germany, 97080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marc Thomas Schmalzing
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dimitrios Boumpas
      • Athens, Greece, 106 76
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Georgios Katsikas
      • Athens, Greece, 124 62
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vasileios Tzilas
      • Larissa, Greece, 41110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dimitrios Bogdanos
  • Italy
      • Ancona, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gianluca Moroncini
      • Milan, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicoletta Del Papa
      • Milan, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorenzo Dagna
      • Modena, Italy, 41124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dilia Giuggioli
      • Napoli, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Ciccia
      • Padua, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luca Iaccarino
      • Pavia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorenzo Cavagna
      • Pisa, Italy, 56126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Mosca
      • Roma, Italy, 00128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Giacomelli
      • Roma, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Antonietta D'Agostino
      • Udine, Italy, 33100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luca Quartuccio
      • Verona, Italy, 37134
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elisa Tinazzi
  • Japan
      • Aichi, Japan, 470-1192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hidekata Yasuoka
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Isamu Okamoto
        • Contact:
        • Contact:
      • Fukuoka, Japan, 807-8556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satoshi Kubo
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomohiro Sugimoto
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michihito Kono
      • Kanagawa, Japan, 216-8511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kimito Kawahata
      • Miyagi, Japan, 983-8512
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomonori Ishii
        • Contact:
        • Contact:
      • Miyazaki, Japan, 889-1692
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kunihiko Umekita
      • Saitama, Japan, 350-0495
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuji Akiyama
      • Tokyo, Japan, 113-8603
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masataka Kuwana
      • Tokyo, Japan, 113-8519
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hirokazu Sasaki
        • Contact:
        • Contact:
      • Tokyo, Japan, 143-8541
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Toshihiro Nanki
      • Tottori, Japan, 683-8504
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akira Yamasaki
      • Yamanashi, Japan, 409-3898
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daiki Nakagomi
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Francisco Pacheco-Tena
      • Guadalajara, Mexico, 44650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Duran
      • Mexicali, Mexico, 21200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Fidencio Cons-Molina
      • Mexico City, Mexico, 03310
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Rojas
      • Monterrey, Mexico, 64460
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Moreno Hoyos Abril
      • Mérida, Mexico, CP 97070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aaron Barrera Rodrguez
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Judith Potjewijd
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jelle Miedema
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renske Vorselaars
  • Panama
      • Panama City, Panama
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilsa Moreno
      • Panama City, Panama, 07126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruno Hammerschlag
      • Panama City, Panama, 7002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorena Noriega
      • Panama City, Panama, 7099
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edgardo Gonzalez Sevillano
  • South Korea
      • Bucheon Kyunggi-Do, South Korea, 420-717
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yong-Hyun Kim
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Man Pyo Chung
      • Seoul, South Korea, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • YONG SUK JO
      • Seoul, South Korea, 05505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kyung-Wook Jo
      • Suwon Kyunggi-do, South Korea, 443-721
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joo Hun Park
      • Yongsan-Ku Seoul, South Korea
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hee-young Yoon
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaume Mestre Torres
      • Barcelona, Spain, 08025
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ivan Castellví Barranco
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alejandro Escudero Contreras
        • Contact:
        • Contact:
      • Granada, Spain, 18016
        • Withdrawn
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gema Bonilla Hernán
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julia Martínez Barrio
      • Málaga, Spain, 29530
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Natalia Mena Vázquez
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Antonio Cascante Rodrigo
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ricardo Blanco Alonso
        • Contact:
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Salvador Garcia Morillo
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Huntley
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fasihul Khan
      • London, United Kingdom, SW3 6NP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Kokosi
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Augustine Chung
      • Los Angeles, California, United States, 90033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Toby Maher
      • Los Angeles, California, United States, 92868
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Huawei Dong
      • San Francisco, California, United States, 94143
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hayley Barnes
      • Upland, California, United States, 91786
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ebrahaim Sadeghi
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faye Pais
      • Naples, Florida, United States, 34102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisette Delgado Sanchez
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam Kilian
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elana Bernstein
      • New York, New York, United States, 10029
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Padilla
        • Contact:
        • Contact:
      • Potsdam, New York, United States, 13676
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eyal Kedar
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lake Morrison
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rohit Gupta
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ivan Rosas
      • Temple, Texas, United States, 76508
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Munish Sharma
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mary Beth Scholand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Participants with persistent/worsening active inflammatory disease who have failed to achieve their treatment goal, i. e., those who have experience lack of expected treatment benefit (clinically meaningful improvement in FVC), fail to demonstrate sustained lung function stability or continue to experience worsening of ILD despite initiation of standard therapy or failed to tolerate standard therapy.
  • Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria
  • Diagnosis of inflammatory and/or fibrotic ILD on High Resolution Computed Tomography (HRCT) with a total disease extent of greater than or equal to (≥) 10% of the whole lung
  • Evidence of persistent active/worsening ILD
  • Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate standard therapy.
  • Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study

  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

    • Is a woman of nonchildbearing potential (WONCBP) OR
    • Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1%
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Diagnosis of ILD other than CTD-ILD.
  • Primary diagnosis of Systemic Sclerosis (SSc).
  • Participants with rapidly progressive disease (absolute drop of 10% or more of FVC between screening and baseline visit and/or recent pulmonary hospitalization).
  • FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted at screening as confirmed by central reader
  • History or presence of diffuse alveolar hemorrhage (DAH) or other confounding pulmonary disease, signs, or symptoms
  • Pulmonary arterial hypertension requiring therapy, as determined by the investigator at, or prior to first day of dosing (Day 1)
  • Dependence on continuous oxygen supplementation
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
  • Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC <0.7) as confirmed by central reader
  • Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD) as confirmed by central reader
  • Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
  • Participants with patient health questionnaire (PHQ-9) score ≥10, that in the opinion of a mental healthcare professional pose a serious suicide risk, have or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk.
  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Breast cancer within the past 10 years
  • Major surgery (including joint surgery) within 3 months prior to screening or planned during the duration of the study
  • An active infection, or a history of infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belimumab
Participants will receive belimumab in addition to standard therapy.
Biological: Belimumab
Belimumab will be administered.
Other Names:
  • BENLYSTA, GSK1550188
Placebo Comparator: Placebo
Participants will receive placebo in addition to standard therapy.
Other: Placebo
Placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52
Time Frame: Baseline and Week 52
Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change from Baseline in FVC Percentage (%) Predicted at Week 52
Time Frame: Baseline and Week 52
FVC are expressed as a percentage of the predicted normal for a person of the same sex, age, and height. Lower % predicted FVC (mL) reflects more impaired lung function.
Baseline and Week 52
Time to ILD Progression or Death
Time Frame: From the date of assignment (Day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
Time taken for a participant to experience ILD progression or death.
From the date of assignment (Day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
Absolute Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 52
Time Frame: Baseline and Week 52
The FACIT-Fatigue is a short, 13-item questionnaire that assesses self-reported fatigue and its associated impact for daily activities over the past 7 days. The scale range is from 0 to 52, with 0 being the worst possible score and 52 being the best possible score (indicating less/no fatigue).
Baseline and Week 52
Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52
Time Frame: Baseline and Week 52
The L-PF questionnaire is a 49-item questionnaire with two modules: 1) symptoms (28 items) and 2) impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Participants rate the severity of their symptoms in the last 24 hour on a 5-point rating scale. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary scores range from 0-100, with the higher the score the greater the impairment.
Baseline and Week 52
Achieving Relative Decline from Baseline in FVC (mL) ≥ 5% at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Time to Connective Tissue Disease Progression
Time Frame: Up to 52 Weeks
Time taken for a participant to experience CTD progression.
Up to 52 Weeks
Absolute Change from Baseline in Transition Dyspnea Index (TDI) at Week 52
Time Frame: Baseline and Week 52
TDI assess dyspnea severity at baseline and its change over time. TDI includes 3 components: functional impairment, magnitude of task and magnitude of effort. Each component has 7 grades, ranging from -3 (major deterioration) to +3 (major improvement), which are summed to calculate a score, ranging between - 9 and +9. Lower score indicates more severely the participant is affected by dyspnea.
Baseline and Week 52
Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2) at Week 52
Time Frame: Baseline and Week 52
The SF-36 yields an 8-scale profile of functional health and well-being scores as well as physical and mental component health summary scores. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score (0) the more disability.
Baseline and Week 52
Absolute Change from Baseline in Physician Global Assessment (PhGA) at Week 52
Time Frame: Baseline and Week 52
The PhGA is a score which enables the treating physician to rate the participants disease on a scale from 0 to 10, where higher score (10) indicates greater severity.
Baseline and Week 52
Absolute Change in Patient Global Impression of Change (PGIC)-ILD at Week 52
Time Frame: Baseline and Week 52
The PGIC contains two items, a global question asking participants to rate their overall change in ILD severity since first starting this study using a 7-point verbal rating scale, and a yes/no question asking participants to indicate whether the change is meaningful from their perspective.
Baseline and Week 52
Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)
Time Frame: Up to Week 60
Up to Week 60
Number of Participants with Respiratory Related Hospitalizations up to Week 52
Time Frame: Up to Week 52
Up to Week 52
Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
Time Frame: Baseline and Week 52
Change from baseline in extent of architectural distortion (fibrosis), ground glass opacification, and honeycombing features on High-resolution computed tomography (HRCT) as measured by computer-aided analysis tools. Extent of ILD is calculated by summing pixel counts and expressing this as a percentage of the whole lung. ILD extent can range from 0-100% with higher percentage representing more extensive ILD.
Baseline and Week 52
Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
Time Frame: Baseline and Week 52
Change from baseline in extent of reticular patterns with architectural distortion (fibrosis) on HRCT as measured by computer-aided analysis tools. Extent of fibrosis is calculated by summing pixel counts and expressing this as a percentage of the whole lung. Fibrosis extent can range from 0-100% with higher percentage representing more extensive fibrosis.
Baseline and Week 52
Achieving Relative Decline from Baseline in FVC (mL) ≥ 10% at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Absolute Change from Baseline in Steroid Dose (Prednisone Equivalent Dose) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Impacts Total Score at Week 52
Time Frame: Baseline and Week 52
The L-PF questionnaire is a 49-item questionnaire with two modules: 1) symptoms (28 items) and 2) impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Participants rate the severity of their symptoms in the last 24 hour on a 5-point rating scale. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary scores range from 0-100, with the higher the score (100) the greater the impairment.
Baseline and Week 52
Absolute Change from Baseline in Quantitative Ground Glass Opacity in the Whole Lung (QGGO-WL) at Week 52
Time Frame: Baseline and Week 52
Change from baseline in extent of ground glass opacification (GGO) on HRCT as measured by computer-aided analysis tools. Extent of GGO is calculated by summing pixel counts and expressing this as a percentage of the whole lung. GGO extent can range from 0-100% with higher percentage representing more extensive GGO.
Baseline and Week 52
Absolute Change from Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) at Week 52
Time Frame: Baseline and Week 52
The K-BILD questionnaire consists of 15 items (assessed by the participants on a scale ranging from 1 to 7, where 1 and 7 represent worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34), and chest symptoms (range: 0-8). Scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status). A total score and 3 domain scores are calculated ranging from 0-100 with greater scores (100) denoting better quality of life.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

October 18, 2028

Study Completion (Estimated)

December 13, 2028

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221672
  • 2024-513018-36-00 (Ctis: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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