A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

September 3, 2018 updated by: Novo Nordisk A/S

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B 1900AXI
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, B1878GEG
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, CA1199ABB
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, C1425DUH
        • Novo Nordisk Investigational Site
      • Ciudad Autonoma Buenos Aires, Argentina, 1113
        • Novo Nordisk Investigational Site
      • Ciudad Autonoma de Buenos Aire, Argentina
        • Novo Nordisk Investigational Site
      • Ciudad de Buenos Aires, Argentina, 1194
        • Novo Nordisk Investigational Site
      • Ciudad de Buenos Aires, Argentina, C1204AAD
        • Novo Nordisk Investigational Site
      • Rosario City, Argentina, S2000PBJ
        • Novo Nordisk Investigational Site
      • San Juan, Argentina, ZC:5400
        • Novo Nordisk Investigational Site
      • Tucuman, Argentina, 4000
        • Novo Nordisk Investigational Site
      • Tucuman, Argentina, T4000BRD
        • Novo Nordisk Investigational Site
  • Belgium
      • Anderlecht, Belgium, 1070
        • Novo Nordisk Investigational Site
      • Kortrijk, Belgium, 8500
        • Novo Nordisk Investigational Site
      • Liege, Belgium, 4000
        • Novo Nordisk Investigational Site
  • Brazil
      • Cuiaba Mount, Brazil, 78040.360
        • Novo Nordisk Investigational Site
      • Curitiba, Brazil, 80440-080
        • Novo Nordisk Investigational Site
      • Rio de Janeiro, Brazil, 22271-100
        • Novo Nordisk Investigational Site
      • Sao Paulo, Brazil, 04266-010
        • Novo Nordisk Investigational Site
      • Sao Paulo, Brazil, 01323-903
        • Novo Nordisk Investigational Site
      • Sao Paulo, Brazil, 05437-010
        • Novo Nordisk Investigational Site
    • Goias
      • Saint Oeste, Goias, Brazil, 74110-120
        • Novo Nordisk Investigational Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Novo Nordisk Investigational Site
    • Parana
      • Curitiba, Parana, Brazil, 80030-110
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01244-030
        • Novo Nordisk Investigational Site
      • Vila Clementino, Sao Paulo, Brazil, 04026-000
        • Novo Nordisk Investigational Site
      • Vila Clementino, Sao Paulo, Brazil, 04032-060
        • Novo Nordisk Investigational Site
  • Czechia
      • Brno, Czechia, 602 00
        • Novo Nordisk Investigational Site
      • Brno, Czechia, 625 00
        • Novo Nordisk Investigational Site
      • Hlucin, Czechia, 748 01
        • Novo Nordisk Investigational Site
      • Pardubice, Czechia, 530 02
        • Novo Nordisk Investigational Site
      • Prague 3, Czechia, 130 00
        • Novo Nordisk Investigational Site
      • Prague 4, Czechia, 14000
        • Novo Nordisk Investigational Site
      • Praha 11, Czechia, 148 00
        • Novo Nordisk Investigational Site
      • Praha 2, Czechia, 128 50
        • Novo Nordisk Investigational Site
      • Zlin, Czechia, 76001
        • Novo Nordisk Investigational Site
  • France
      • Echirolles, France, 38130
        • Novo Nordisk Investigational Site
      • Nantes Cedex 01, France, 44093
        • Novo Nordisk Investigational Site
      • Orleans, France, 45032
        • Novo Nordisk Investigational Site
      • Rennes, France, 35033
        • Novo Nordisk Investigational Site
  • Germany
      • Aachen, Germany, 52064
        • Novo Nordisk Investigational Site
      • Bad Kreuznach, Germany, 5543
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60528
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22081
        • Novo Nordisk Investigational Site
      • Herne, Germany, 44649
        • Novo Nordisk Investigational Site
      • Koein, Germany, D-50937
        • Novo Nordisk Investigational Site
      • Vogelsang-Gommern, Germany, 39245
        • Novo Nordisk Investigational Site
  • Hungary
      • Kiskunhalas, Hungary, 6400
        • Novo Nordisk Investigational Site
  • Italy
      • Arenzano, Italy, 16011
        • Novo Nordisk Investigational Site
      • Firenze, Italy, 50139
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16132
        • Novo Nordisk Investigational Site
      • Jesi, Italy, 60035
        • Novo Nordisk Investigational Site
      • Rome, Italy, 161
        • Novo Nordisk Investigational Site
      • Verona, Italy, 37134
        • Novo Nordisk Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31000
        • Novo Nordisk Investigational Site
      • Mexico City, Mexico, 07760
        • Novo Nordisk Investigational Site
      • Mexico City, Mexico, C.P. 06700
        • Novo Nordisk Investigational Site
      • Mexico City, Mexico, 03100
        • Novo Nordisk Investigational Site
      • Monterrey N.L., Mexico, 64000
        • Novo Nordisk Investigational Site
      • Roma, Mexico, 06700
        • Novo Nordisk Investigational Site
      • San Luis Potosi, Mexico, 78200
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Mexico, México, D.F., Mexico, 06700
        • Novo Nordisk Investigational Site
      • Mexico City, México, D.F., Mexico, 06100
        • Novo Nordisk Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Novo Nordisk Investigational Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-879
        • Novo Nordisk Investigational Site
      • Gdynia, Poland, 81-384
        • Novo Nordisk Investigational Site
      • Katowice, Poland, 40-040
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 30119
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-218
        • Novo Nordisk Investigational Site
      • Sroda Wielkopolska, Poland, 63-000
        • Novo Nordisk Investigational Site
      • Warsaw, Poland, 01-868
        • Novo Nordisk Investigational Site
      • Warsaw, Poland, 04-141
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-381
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656024
        • Novo Nordisk Investigational Site
      • Barnaul, Russian Federation, 656055
        • Novo Nordisk Investigational Site
      • Ekaterinburg, Russian Federation, 620102
        • Novo Nordisk Investigational Site
      • Kemerovo, Russian Federation, 193257
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119049
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 115522
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630008
        • Novo Nordisk Investigational Site
      • Petrozavodsk, Russian Federation, 185019
        • Novo Nordisk Investigational Site
      • Smolensk, Russian Federation, 214025
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 190068
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 197341
        • Novo Nordisk Investigational Site
      • Stavropol, Russian Federation, 355017
        • Novo Nordisk Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Novo Nordisk Investigational Site
  • Spain
      • Guadalajara, Spain, 19002
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28942
        • Novo Nordisk Investigational Site
      • Malaga, Spain, 29009
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41014
        • Novo Nordisk Investigational Site
      • Seville, Spain, 41009
        • Novo Nordisk Investigational Site
      • Seville, Spain, 41010
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46010
        • Novo Nordisk Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83045
        • Novo Nordisk Investigational Site
      • Donetsk, Ukraine, 83114
        • Novo Nordisk Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Novo Nordisk Investigational Site
      • Kharkiv, Ukraine, 61039
        • Novo Nordisk Investigational Site
      • Kharkiv, Ukraine, 61176
        • Novo Nordisk Investigational Site
      • Kiev, Ukraine, 1601
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 02232
        • Novo Nordisk Investigational Site
      • Lugansk, Ukraine, 91045
        • Novo Nordisk Investigational Site
      • Odesa, Ukraine, 65026
        • Novo Nordisk Investigational Site
      • Poltava, Ukraine, 36011
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21018
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21029
        • Novo Nordisk Investigational Site
      • Vinnytsya, Ukraine, 210029
        • Novo Nordisk Investigational Site
      • Vinnytsya, Ukraine, 21029
        • Novo Nordisk Investigational Site
      • Zaporizhzhia, Ukraine, 69104
        • Novo Nordisk Investigational Site
      • Zaporizhzhia, Ukraine, 69600
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Huntington Beach, California, United States, 92646
        • Novo Nordisk Investigational Site
      • La Mesa, California, United States, 91942
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90022
        • Novo Nordisk Investigational Site
      • Placentia, California, United States, 92870
        • Novo Nordisk Investigational Site
      • Upland, California, United States, 91786
        • Novo Nordisk Investigational Site
    • Florida
      • Palm Harbor, Florida, United States, 34684
        • Novo Nordisk Investigational Site
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62704
        • Novo Nordisk Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Novo Nordisk Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401-2112
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67206
        • Novo Nordisk Investigational Site
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701-2988
        • Novo Nordisk Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Novo Nordisk Investigational Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Novo Nordisk Investigational Site
    • Montana
      • Kalispell, Montana, United States, 59901
        • Novo Nordisk Investigational Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08755
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • New York
      • Brooklyn, New York, United States, 11201-4326
        • Novo Nordisk Investigational Site
      • Lake Success, New York, United States, 11042
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Novo Nordisk Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77008
        • Novo Nordisk Investigational Site
      • Mesquite, Texas, United States, 75150-5615
        • Novo Nordisk Investigational Site
    • West Virginia
      • Beckley, West Virginia, United States, 25801-2805
        • Novo Nordisk Investigational Site

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010 - Active RA, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. C-reactive protein (CRP) above or equal to 1.0 mg/dL (10 mg/L) - Patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. Methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance b. Hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit Exclusion Criteria: - Patients with arthritis due to other autoimmune diseases than RA - Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) - History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy - Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit - Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant - Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Placebo
Drug: placebo
Administered subcutaneously (s.c., under the skin), once weekly.
EXPERIMENTAL: 60 mg
Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.
EXPERIMENTAL: 120 mg
Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.
EXPERIMENTAL: 240 mg
Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
Time Frame: At week 12 (responder or non-responder)
At week 12 (responder or non-responder)

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time Frame: Week 52
Week 52
Incidence and type of adverse events (AEs)
Time Frame: Week 52
Week 52
ACR20, ACR50 and ACR70 improvement of ACR score from baseline
Time Frame: At weeks 12 and 24
At weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
Time Frame: At weeks 12 and 24
At weeks 12 and 24
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
Time Frame: At weeks 12 and 24
At weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response
Time Frame: At weeks 12 and 24
At weeks 12 and 24
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
Time Frame: At weeks 12 and 24
At weeks 12 and 24
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: At weeks 12 and 24
At weeks 12 and 24
Incidence and type of adverse events (AEs)
Time Frame: At weeks 12 and 24
At weeks 12 and 24
Change from baseline in van der Heijde modified Sharp score
Time Frame: At weeks 12 and 24
At weeks 12 and 24

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

October 30, 2012

Primary Completion (ACTUAL)

November 10, 2014

Study Completion (ACTUAL)

November 10, 2014

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (ESTIMATE)

July 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8226-3613
  • 2012-000610-11 (EUDRACT_NUMBER)
  • U1111-1127-9324 (OTHER: WHO)

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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