Phase 2
Completed N=251
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02287922 ↗Enrolled (actual)
251
Serious AEs
2.0%
Results posted
Aug 2019
Primary outcomePrimary: Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12 — 45; 48; 51; 50 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12 |
45; 48; 51; 50 | — |
| SECONDARY Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12 |
27; 23; 31; 29; 10; 15 | — |
| SECONDARY 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 |
26; 35; 38; 28 | — |
| SECONDARY Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12 |
26; 32; 34; 20 | — |
| SECONDARY Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12 |
23; 27; 33; 22 | — |
| SECONDARY Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12 |
23; 21; 32; 21 | — |
| SECONDARY Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12 |
25; 34; 38; 28 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12 |
21; 13; 25; 16 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using SDAI at Week 12 |
5; 3; 5; 7 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using CDAI at Week 12 |
6; 3; 4; 6 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12 |
2; 3; 4; 4 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 |
-0.541; -0.746; -0.817; -0.689 | — |
| SECONDARY Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12 |
7.808; 7.979; 8.861; 7.611; 5.49; 8.836 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12 |
7.832; 11.41; 12.996; 8.971 | — |
| SECONDARY Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) |
33.0; 42.3; 30.9; 31.0; 376; 460 | — |
| SECONDARY Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12 |
1.4; 18.4; 27.9 | — |
| SECONDARY Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response |
7; 25; 26; 58 | — |
| SECONDARY Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity |
22; 18; 21; 19; 12; 13 | — |
| SECONDARY Number of Treatment-emergent Adverse Event by Severity |
46; 75; 84; 47; 18; 22 | — |
| SECONDARY Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event |
21; 20; 21; 20 | — |
| SECONDARY Number of Treatment-related Treatment-emergent Adverse Event |
46; 53; 64; 32 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02287922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.