A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (BLISSc-ILD)

January 3, 2024 updated by: GlaxoSmithKline

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Study Overview

Study Type

Interventional

Enrollment (Estimated)

300

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

      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Jose Lopez Meiller
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María N Tamborenea
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Oliffe
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Susanna Proudman
      • Woodville, South Australia, Australia, 5011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maureen Rischmueller
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wendy Stevens
      • Gent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanessa Smith
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Wim Wuyts
        • Contact:
        • Contact:
      • São Paulo, Brazil, 04038-002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristiane da Silva
    • Bahía
      • Salvador, Bahía, Brazil, 40.150-150
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mittermayer Santiago
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150221
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thales Henrique Viana Azevedo
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viviane Angelina de Souza
    • Paraná
      • Curitba, Paraná, Brazil, 80440-080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valderilio Azevedo
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adalberto Sperb Rubin
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mauro Waldemar Keiserman
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01308-050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Percival Barros
    • Ontario
      • Toronto, Ontario, Canada, M5T 3L9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zareen Ahmad
      • Beijing, China, 100020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuewu Lu
      • Beijing, China, 100029
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xin Lu
        • Contact:
        • Contact:
      • Beijing, China, 100730
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xuan Zhang
      • Beijing, China, 100191
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rong Mu
      • Luzhou, China, 648000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chengsong He
      • Mianyang, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jing Yang
      • Nanjing, China, 210008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lingyun Sun
        • Contact:
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hejian Zou
        • Contact:
        • Contact:
      • Shanghai, China, 200001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ting Li
      • Shenyang, China, 110001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pingting Yang
      • Xian, China, 710061
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lan He
        • Contact:
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jinying Lin
      • Nanning, Guangxi, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ling Lei
    • Hunan
      • ZhuZhou, Hunan, China, 412007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jingyang Li
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wenfeng Tan
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zhenyu Jiang
        • Contact:
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yi Liu
        • Contact:
        • Contact:
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jing Zhu
      • Aarhus, Denmark, 8200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Klaus Sondergaard
      • Køge, Denmark, 4600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ada Colic
      • Odense C, Denmark, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Titlestad
      • Turku, Finland, 20520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Pirila
      • Bobigny, France, 93000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yurdagul Uzunhan
      • Paris, France, 75014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yannick Allanore
      • Paris Cedex 13, France, 75651
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zahir Amoura
      • Strasbourg, France, 67000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne Sophie Korganow
      • Toulouse cedex 9, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Grégory Pugnet
      • Bad Abbach, Germany, 93077
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Fleck
    • Baden-Wuerttemberg
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joerg Henes
        • Contact:
        • Contact:
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joerg Distler
      • Minden, Nordrhein-Westfalen, Germany, 32429
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gunter Assmann
      • Wuppertal, Nordrhein-Westfalen, Germany, 42105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Annette Alberding
      • Athens, Greece, 12462
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dimitrios Boumpas
      • Heraklion-Crete, Greece, 71110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katerina Antoniou
      • Larissa, Greece, 41110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dimitrios Bogdanos
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Theodoros Dimitroulas
    • Attiki
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Panayiotis Vlachoyiannopoulos
      • Haifa, Israel, 3436212
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Devy Zisman
      • Kfar Saba, Israel, 44281
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yair Levy
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irena Litinsky
      • Tel Hashomer, Israel, 52621
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Merav Lidar
        • Contact:
        • Contact:
      • Tiberias, Israel, 15208
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sabbah Firas
      • Firenze, Italy, 50134
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Serena Guiducci
      • Napoli, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanna Cuomo
      • Verona, Italy, 37134
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elisa Tinazzi
    • Emilia-Romagna
      • Cona (Ferrara), Emilia-Romagna, Italy, 44124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcello Govoni
      • Modena, Emilia-Romagna, Italy, 41125
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dilia Giuggioli
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valeria Riccieri
      • Roma, Lazio, Italy, 00186
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Antonietta D'Agostino
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicoletta Del Papa
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Veronica Codullo
    • Marche
      • Torrette, Marche, Italy, 60126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gianluca Moroncini
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renato Carignola
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florenzo Iannone
    • Sardegna
      • Monserrato, Sardegna, Italy, 09042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto Cauli
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosario Foti
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elisabetta Zanatta
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seiichiro Motegi
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Masaru Kato
        • Contact:
        • Contact:
      • Hokkaido, Japan, 060-8543
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroki Takahashi
      • Kanagawa, Japan, 236-0051
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erina Tabata
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomonori Ishii
        • Contact:
        • Contact:
      • Tokyo, Japan, 113-8603
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masataka Kuwana
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Woo Song
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sung Hwan Park
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae-Bum Jun
      • Seoul, Korea, Republic of, 140 887
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyun-Sook Kim
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chang-Hee Suh
        • Contact:
        • Contact:
      • Chihuahua, Mexico, 31000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Francisco Pacheco Tena
    • Ciudad De Mexico
      • Mexico City, Ciudad De Mexico, Mexico, 14080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Rojas-Serrano
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Sicsik Ayala
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sergio Duran-Barragan
        • Contact:
        • Contact:
    • Yucatán
      • Merida, Yucatán, Mexico, CP 97070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Aaron Alejandro Barrera Rodriguez
        • Contact:
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gerard Espinosa Garriga
      • Barcelona, Spain, ?08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alfredo Guillén del Castillo
      • Bilbao, Spain, 48013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Esther Ruiz Lucea
      • Granada, Spain, 18016
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jose Luis Callejas Rubio
        • Contact:
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sara García Carazo
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julia Martínez Barrio
      • Sevilla, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salvador García Morillo
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Andrés Román Ivorra
      • Vigo/ Pontevedra, Spain, 36200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Maria Pego Reigosa
      • Edgbaston, United Kingdom, B15 2GW
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emma Derrett-Smith
      • Leeds, United Kingdom, LS7 4SA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco DelGaldo
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Christopher Denton
        • Contact:
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Da-Wei Liao
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Sue
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vivek Nagaraja
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sachin Chaudhary
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suzanne Kafaja
      • Los Angeles, California, United States, 90045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Furst
      • Upland, California, United States, 91786
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ebrahim Sadeghi-Najafabadi
    • Colorado
      • Aurora, Colorado, United States, 80033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joyce Lee
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Virginia Steen
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ibrahim Faruqi
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jane E Dematte D'Amico
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zsuzsanna McMahan
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erica Mulcaire-Jones
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vivien Hsu
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David H Goddard
      • New York, New York, United States, 10021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Spiera
      • Potsdam, New York, United States, 13676
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eyal Kedar
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachel Foot
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lawrence Brent
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chris Derk
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Margaret Kypreos
      • El Paso, Texas, United States, 79902
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sanjay Chabra
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodney J. Folz

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:

  1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
  2. Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
  3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1.
  4. Total mRSS ≥15 on Day 1.
  5. Evidence of interstitial lung disease on centrally read screening HRCT.
  6. Anticentromere antibody negative on central test at screening.
  7. Evidence for active or progressive disease
  8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh.
  9. 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.
  10. 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 Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective.

  11. Capable of giving signed informed consent.

Exclusion Criteria:

  1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents [nephrogenic systemic fibrosis], or due to metabolic disease).
  2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator.
  3. FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.
  4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
  5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
  6. 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.
  7. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC <0.7).
  8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
  9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).
  10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is longer) prior to dosing.
  11. Treatment with rituximab within 6 months prior to Day 1.
  12. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine (including, but not limited to cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1.
  13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.
  14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4 weeks prior to Day 1.
  15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.
  16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.

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.
Belimumab will be administered.
Other Names:
  • BENLYSTA™, GSK1550188, LymphoStat-B™
  • BENLYSTATM, GSK1550188, LymphoStat-B™
Placebo Comparator: Placebo
Participants will receive placebo in addition to standard therapy.
.Placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in Forced Vital Capacity (FVC) millilitre (mL) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Time Frame: Baseline and Week 52
The modified Rodnan Skin Score (mRSS) is an evaluation of the patients skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The assessment is made across 17 pre-defined areas of the body, with total score ranging between 0 and 51. Higher scores indicate worse skin thickening.
Baseline and Week 52
Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 52
Time Frame: Baseline and Week 52
FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including SSc. FACIT-Fatigue scores range from 0-52 (higher scores indicate less fatigue).
Baseline and Week 52
Time to Systemic sclerosis (SSc) progression or death
Time Frame: From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks
SSc progression or death is defined as the time when major organ-based complications develop, or the participant dies.
From the date of assignment 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 FVC percentage (%) predicted at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Relative decline from baseline in FVC (mL) greater than or equal to (≥)5% at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
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 mRSS at Week 26
Time Frame: Baseline and Week 26
The modified Rodnan Skin Score (mRSS) is an evaluation of the patients skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold. The assessment is made across 17 pre-defined areas of the body and therefore the total score can range from 0 to 51. Higher scores indicate worse skin thickening.
Baseline and Week 26
Proportion of participants achieving ≥20% increase in mRSS at Week 26 & 52
Time Frame: At Week 26 and Week 52
At Week 26 and Week 52
Absolute change from baseline in Quantitative interstitial lung disease - whole lung (QILD-WL) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Absolute change from baseline in Quantitative lung fibrosis - whole lung (QLF-WL) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Proportion of participants achieving ≥2% increase in QILD at Week 52
Time Frame: At Week 52
At Week 52
Absolute change from baseline in Carbon monoxide diffusing capacity (DLco) % predicted at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Relative decline from baseline in DLco % predicted ≥15% at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Absolute change from baseline in Scleroderma Skin Patient-Reported Outcome (SSPRO) at Week 52
Time Frame: Baseline and Week 52
SSPRO a patient-reported outcome (PRO) instrument developed to assess the skin-related quality of life (QoL) in participants with SSc. SSPRO has 18 items that assess four SSc skin-related HRQoL domain (emotional effects, physical effects, physical limitations and social effects). The higher score indicates worse impact on QoL.
Baseline and Week 52
Absolute change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Time Frame: Baseline and Week 52
The HAQ-DI is a 26-question instrument assessing the degree of difficulty in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each question is scored 0-3 (where 0=without difficulty & 3=unable to do). Higher scores reflect worse disability
Baseline and Week 52
Absolute change from baseline in Short Form-36 Health Survey Questionnaire (SF-36) 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 the more disability.
Baseline and Week 52
Absolute change from baseline in Patient Global Assessment of SSc Disease Activity (PtGA) at Week 52.
Time Frame: Baseline and Week 52
PtGA is a patient reported outcome scale designed to capture the participants overall assessment of their disease. The participants are asked to score their disease on a scale from 0 to 10 where higher score indicates higher severity
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 indicates greater severity.
Baseline and Week 52
Absolute change from baseline in Transition Dyspnea Index (TDI) at Week 52
Time Frame: Baseline and Week 52
TDI assess dyspnea severity over 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. The lower the score the more severely the participant is affected by dyspnea.
Baseline and Week 52
Number of participants with Adverse Events (AEs), Adverse Events of special interest (AESIs) and Serious AEs (SAEs) up to Week 52
Time Frame: Up to Week 52
Up to Week 52
Absolute change from baseline in DLco % predicted at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Absolute change from baseline in Cough Numeric Rating Scale (NRS) at Week 52
Time Frame: Baseline and Week 52
The cough NRS enables the participant to rate their cough on a defined scale from 0 to 10, where higher score indicating worse cough symptoms.
Baseline and Week 52

Collaborators and Investigators

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

Sponsor

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 13, 2023

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

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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