A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02309359
• Date of registration: 27/11/2014
• Prospective Registration: Yes
• Primary sponsor: Ablynx
• Public title: A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
• Scientific title: A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
• Date of first enrolment: January 2015
• Target sample size: 345
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02309359
• 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: Ablynx Clinical Department
• Affiliation: Ablynx

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of RA for at least 6 months prior to screening, and American College of
Rheumatology (ACR) functional class I-III

- Subjects treated with and tolerating MTX

- Active RA

- Others as defined in the protocol

Exclusion Criteria:

- Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic
immunosuppressives other than MTX.

- Have received approved or investigational biological or targeted synthetic DMARD
therapies for RA 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, 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: ALX-0061

Drug: Methotrexate

Other: Placebo

Primary Outcome(s)

Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24 [Time Frame: from baseline till Week 24]

Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With ACR20 Response at Week 24 [Time Frame: 24 weeks]

Number of Treatment-related Treatment-emergent Adverse Events [Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit]

Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events [Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit]

Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24 [Time Frame: from baseline till Week 24]

Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 [Time Frame: from baseline till Week 24]

Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 [Time Frame: from baseline till Week 24]

Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24 [Time Frame: 24 weeks]

Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response [Time Frame: from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation)]

Number of Treatment-emergent Adverse Events by Severity [Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit]

Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24 [Time Frame: at Week 12 and Week 24 visits]

Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24 [Time Frame: 24 weeks]

Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity [Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit]

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24 [Time Frame: from baseline till Week 24]

Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24 [Time Frame: 24 weeks]

Secondary ID(s)

ALX0061-C201

2014-003033-26

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/NCT02309359