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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02287922
• Date of registration: 05/11/2014
• Prospective Registration: Yes
• Primary sponsor: Ablynx
• Public title: A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
• Scientific title: A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
• Date of first enrolment: March 2015
• Target sample size: 251
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02287922
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Czechia, Georgia, Germany, Hungary, Macedonia, The Former Yugoslav Republic of, Mexico, Moldova, Republic of, North Macedonia, Poland, Romania, Serbia, Spain, United States

Contacts

• Name: Medical Monitor, MD
• Affiliation: Ablynx

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Placebo

Biological: ALX-0061

Biological: Tocilizumab

Primary Outcome(s)

Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12 [Time Frame: From baseline until 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 [Time Frame: Week 12]

Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12 [Time Frame: From baseline until week 12]

Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity [Time Frame: From baseline until Week 12]

Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects in Remission Using CDAI at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects in Remission Using SDAI at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12 [Time Frame: Week 12]

Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12 [Time Frame: From baseline until Week 12]

Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event [Time Frame: From baseline until Week 12]

Number of Treatment-emergent Adverse Event by Severity [Time Frame: From baseline until Week 12]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 [Time Frame: From baseline until Week 12]

Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response [Time Frame: From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU)]

Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12 [Time Frame: Week 12]

Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12 [Time Frame: Week 12]

Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) [Time Frame: From baseline until Week 12]

Number of Treatment-related Treatment-emergent Adverse Event [Time Frame: From baseline until Week 12]

Secondary ID(s)

ALX0061-C202

2014-003012-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02287922