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

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 Anti-TNFa Biologics

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 s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Rheumatoid Arthritis
• Intervention / Treatment: Drug: NNC0109-0012; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 2

Contacts and Locations

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
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Novo Nordisk Investigational Site
  • Ciudad de Buenos Aires, Argentina, 1194
    • Novo Nordisk Investigational Site
  • Cordoba, Argentina, X5002HWE
    • 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
• Belgium
  • Anderlecht, Belgium, 1070
    • Novo Nordisk Investigational Site
  • Kortrijk, Belgium, 8500
    • Novo Nordisk Investigational Site
  • Liege, Belgium, 4000
    • Novo Nordisk Investigational Site
• Brazil
  • Cuiabá - Mount, Brazil, 78040-360
    • Novo Nordisk Investigational Site
  • Curitiba, Brazil, 80440-080
    • Novo Nordisk Investigational Site
  • Rio Grande De Sul, Brazil, 91350-200
    • Novo Nordisk Investigational Site
  • Sao Paulo, Brazil, 04266-010
    • 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
    • Santa Efigenia-Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • 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
  • Hlucin, Czechia, 748 01
    • Novo Nordisk Investigational Site
  • Praha 2, Czechia, 128 50
    • Novo Nordisk Investigational Site
  • Zlin, Czechia, 76001
    • Novo Nordisk Investigational Site
• France
  • Bois Guillaume, France, 76230
    • Novo Nordisk Investigational Site
  • Bordeaux, France, 35033
    • Novo Nordisk Investigational Site
  • Echirolles, France, 38130
    • Novo Nordisk Investigational Site
  • Lyon Cedex 3, France, 69437
    • 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
  • 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
  • Debrecen, Hungary, 4031
    • Novo Nordisk Investigational Site
  • Veszprem, Hungary, 8200
    • 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
  • Torrette Di Ancona, Italy, 60126
    • 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
  • 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 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
  • Krakow, Poland, 30119
    • Novo Nordisk Investigational Site
  • Poznan, Poland, 61-218
    • Novo Nordisk Investigational Site
  • Sroda Wielkopolska, Poland, 63-000
    • 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
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Novo Nordisk Investigational Site
  • Eastbourne, United Kingdom, BN21 2UD
    • Novo Nordisk Investigational Site
  • Maidstone, United Kingdom, ME169QQ
    • Novo Nordisk Investigational Site
  • Sheffield, United Kingdom, SJO 2SJ
    • Novo Nordisk Investigational Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Novo Nordisk Investigational Site
    • Tuscaloosa, Alabama, United States, 35406
      • Novo Nordisk Investigational Site
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Novo Nordisk Investigational Site
    • Phoenix, Arizona, United States, 85037
      • Novo Nordisk Investigational Site
    • Scottsdale, Arizona, United States, 85258-4523
      • Novo Nordisk Investigational Site
  • California
    • Glendale, California, United States, 91204
      • Novo Nordisk Investigational Site
    • Hemet, California, United States, 92543
      • Novo Nordisk Investigational Site
    • Huntington Beach, California, United States, 92646
      • Novo Nordisk Investigational Site
    • La Mesa, California, United States, 91942
      • Novo Nordisk Investigational Site
    • Lakewood, California, United States, 90712
      • Novo Nordisk Investigational Site
    • Long Beach, California, United States, 90806
      • Novo Nordisk Investigational Site
    • Long Beach, California, United States, 90808-2146
      • Novo Nordisk Investigational Site
    • Los Angeles, California, United States, 90022
      • Novo Nordisk Investigational Site
    • Placentia, California, United States, 92870
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92101
      • Novo Nordisk Investigational Site
    • Santa Monica, California, United States, 90409
      • Novo Nordisk Investigational Site
    • Upland, California, United States, 91786
      • Novo Nordisk Investigational Site
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Novo Nordisk Investigational Site
    • Fort Lauderdale, Florida, United States, 33334
      • Novo Nordisk Investigational Site
    • Gainesville, Florida, United States, 32607
      • Novo Nordisk Investigational Site
    • Jupiter, Florida, United States, 33468
      • Novo Nordisk Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Novo Nordisk Investigational Site
    • Ocala, Florida, United States, 34474
      • Novo Nordisk Investigational Site
    • Orlando, Florida, United States, 32804
      • Novo Nordisk Investigational Site
    • Tampa, Florida, United States, 33613
      • Novo Nordisk Investigational Site
    • Venice, Florida, United States, 34292
      • Novo Nordisk Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • Novo Nordisk Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Novo Nordisk Investigational Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • 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
    • Kansas City, Kansas, United States, 66160
      • Novo Nordisk Investigational Site
    • 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
    • Shreveport, Louisiana, United States, 71105
      • Novo Nordisk Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Novo Nordisk Investigational Site
    • Columbia, Maryland, United States, 21045
      • Novo Nordisk Investigational Site
    • Cumberland, Maryland, United States, 21502
      • Novo Nordisk Investigational Site
    • Hagerstown, Maryland, United States, 21740
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Novo Nordisk Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0100
      • Novo Nordisk Investigational Site
    • Battle Creek, Michigan, United States, 49018
      • Novo Nordisk Investigational Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232-9306
      • Novo Nordisk Investigational Site
    • Flowood, Mississippi, United States, 39232
      • Novo Nordisk Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Novo Nordisk Investigational Site
    • Saint Louis, Missouri, United States, 63139-2338
      • Novo Nordisk Investigational Site
    • Saint Louis, Missouri, United States, 63141-6819
      • Novo Nordisk Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Novo Nordisk Investigational Site
  • New Jersey
    • Clifton, New Jersey, United States, 07012
      • Novo Nordisk Investigational Site
    • 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
    • Albany, New York, United States, 12206
      • Novo Nordisk Investigational Site
    • Brooklyn, New York, United States, 11201-4326
      • Novo Nordisk Investigational Site
    • Lake Success, New York, United States, 11042
      • Novo Nordisk Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Novo Nordisk Investigational Site
    • Charlotte, North Carolina, United States, 28210
      • Novo Nordisk Investigational Site
    • Greensboro, North Carolina, United States, 27408
      • Novo Nordisk Investigational Site
    • Raleigh, North Carolina, United States, 27617
      • Novo Nordisk Investigational Site
    • Wilmington, North Carolina, United States, 28401-6442
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novo Nordisk Investigational Site
    • Columbus, Ohio, United States, 43203
      • Novo Nordisk Investigational Site
    • Toledo, Ohio, United States, 43606
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Novo Nordisk Investigational Site
    • Oklahoma City, Oklahoma, United States, 73103
      • Novo Nordisk Investigational Site
    • Tulsa, Oklahoma, United States, 74135
      • Novo Nordisk Investigational Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Novo Nordisk Investigational Site
    • Lake Oswego, Oregon, United States, 07035
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Novo Nordisk Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Novo Nordisk Investigational Site
    • Charleston, South Carolina, United States, 29407-7757
      • Novo Nordisk Investigational Site
    • Columbia, South Carolina, United States, 29204-2409
      • Novo Nordisk Investigational Site
    • 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
    • Memphis, Tennessee, United States, 38104
      • Novo Nordisk Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79124
      • Novo Nordisk Investigational Site
    • Austin, Texas, United States, 78721
      • Novo Nordisk Investigational Site
    • Carrollton, Texas, United States, 75007
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77008
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77090
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77034
      • Novo Nordisk Investigational Site
    • McKinney, Texas, United States, 75071
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77479
      • Novo Nordisk Investigational Site
    • Waco, Texas, United States, 76708-3244
      • Novo Nordisk Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Novo Nordisk Investigational Site
  • Washington
    • Seattle, Washington, United States, 98122
      • Novo Nordisk Investigational Site
    • Tacoma, Washington, United States, 98405
      • Novo Nordisk Investigational Site
  • West Virginia
    • Beckley, West Virginia, United States, 25801-2805
      • Novo Nordisk Investigational Site

Participation Criteria

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. above 5 tender and above 5 swollen joints based on a 28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
• Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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)	At Week 12 (i.e., responder or non-responder)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 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: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Inflammation
• Other Study ID Numbers: NN8226-3612; 2012-000609-58 (EudraCT Number); U1111-1127-9273 (Other Identifier: WHO)