A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

NCT02287922 | Completed Phase 2 Results DMC

• 2 other identifiers: ALX0061-C2022014-003012-36
• Study Type: interventional
• Target: 251
• Locations: 14 countries
• Sites: 83

Brief Summary

The primary objective of this study is: \- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are:

• To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development.
• To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12

  ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.

  Week 12

Secondary Outcomes (20)

• Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12

  Week 12

• Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12

  Week 12

• Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12

  Week 12

• Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12

  Week 12

• Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12

  Week 12

Study Arms (4)

ALX-0061 150 mg q4w

EXPERIMENTAL

ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.

Biological: ALX-0061; Biological: Placebo

ALX-0061 150 mg q2w

EXPERIMENTAL

ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.

Biological: ALX-0061; Biological: Placebo

ALX-0061 225 mg q2w

EXPERIMENTAL

ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.

Biological: ALX-0061

TCZ 162 mg q1w or q2w

ACTIVE COMPARATOR

Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).

Biological: Tocilizumab

Interventions

ALX-0061 BIOLOGICAL

ALX-0061 150 mg q2w; ALX-0061 150 mg q4w; ALX-0061 225 mg q2w

Placebo BIOLOGICAL

ALX-0061 150 mg q2w; ALX-0061 150 mg q4w

Tocilizumab BIOLOGICAL

TCZ 162 mg q1w or q2w

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
• Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
• Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
• Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
• Others as defined in the protocol

You may not qualify if:

• Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
• Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase \[JAK\]-inhibitors) less than 6 months prior to screening.
• Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA.
• Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
• Others as defined in the protocol.

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (83)

Investigator Site

Birmingham, Alabama, 35216, United States

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Hemet, California, 92543, United States

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La Palma, California, 90712, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90036, United States

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Ventura, California, 93003, United States

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Hialeah, Florida, 33016, United States

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Homestead, Florida, 33030, United States

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Orlando, Florida, 32804, United States

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Stockbridge, Georgia, 30281, United States

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Overland Park, Kansas, 66209, United States

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Worcester, Massachusetts, 01605, United States

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Albuquerque, New Mexico, 87102, United States

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New York, New York, 10018, United States

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Charleston, South Carolina, 29406, United States

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Memphis, Tennessee, 38119, United States

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Mesquite, Texas, 75150, United States

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Liège, 4000, Belgium

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Burgas, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Brno, 602000, Czechia

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Olomouc, Czechia

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Ostrava, 70300, Czechia

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Prague, Czechia

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Prague, Czechia

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Zlín, Czechia

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Tbilisi, 0102, Georgia

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Tbilisi, 0159, Georgia

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Tbilisi, 0159, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0179, Georgia

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Berlin, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Baja, 6500, Hungary

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Budapest, Hungary

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Esztergom, Hungary

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Gyula, 5700, Hungary

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Székesfehérvar, 8000, Hungary

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Szikszó, 3800, Hungary

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Szombathely, 9700, Hungary

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Veszprém, 8200, Hungary

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Culiacán, Mexico

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León, Mexico

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Mexico City, Mexico

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Mexico City, Mexico

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Mexico City, Mexico

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Monterrey, Mexico

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Monterrey, Mexico

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Chisinau, 2025, Moldova

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Chisinau, Moldova

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Skopje, 1000, North Macedonia

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Skopje, 1000, North Macedonia

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Bydgoszcz, Poland

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Elblag, 82300, Poland

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Elblag, Poland

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Gdynia, Poland

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Grodzisk Mazowiecki, 05825, Poland

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Lublin, 20582, Poland

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Poznan, 60773, Poland

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Sochaczew, 96500, Poland

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Torun, 87100, Poland

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Warsaw, 02653, Poland

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Bucharest, Romania

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Oradea, Romania

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Timișoara, Romania

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Belgrade, Serbia

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Belgrade, Serbia

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Belgrade, Serbia

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Niška Banja, Serbia

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Córdoba, Spain

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Madrid, 28007, Spain

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Santander, 39300, Spain

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Santander, Spain

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Santiago de Compostela, Spain

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Santiago de Compostela, Spain

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ALX-0061; tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Monitor
• Organization: Ablynx NV

clinicaltrials@ablynx.com

+32 (0)9 262 00 00

Study Officials

• Medical Monitor, MD

  Ablynx, a Sanofi company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 11, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 21, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-08

Locations

DE (3); RO (3); BU (7); BE (3); ME (7); CZ (6); MO (2); GE (5); US (17); NO (2); HU (8); PL (10); SE (4); ES (6)