Phase 2
Completed N=345
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02309359 ↗Enrolled (actual)
345
Serious AEs
4.6%
Results posted
Aug 2019
Primary outcomePrimary: Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12 — 52; 57; 53; 50 Participants — p=0.172
Summary
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.
To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12 |
52; 57; 53; 50; 43 | 0.172 |
| SECONDARY Number and Percentage of Subjects With ACR20 Response at Week 24 |
51; 55; 49; 52; 51 | — |
| SECONDARY Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24 |
20; 31; 28; 31; 19; 33 | — |
| SECONDARY Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24 |
10; 15; 13; 12; 6; 16 | — |
| SECONDARY 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 |
16; 37; 32; 40; 16; 26 | — |
| SECONDARY Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24 |
13; 36; 29; 33; 11; 24 | — |
| SECONDARY Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24 |
49; 34; 29; 25; 17; 29 | — |
| SECONDARY Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24 |
22; 31; 26; 23; 17; 29 | — |
| SECONDARY Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24 |
15; 36; 30; 39; 15; 26 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24 |
3; 26; 15; 21; 6; 17 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24 |
2; 8; 6; 5; 3; 7 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24 |
3; 7; 4; 5; 3; 10 | — |
| SECONDARY Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24 |
0; 5; 2; 4; 3; 6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24 |
-0.696; -0.619; -0.771; -0.615; -0.613; -0.82 | — |
| SECONDARY Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 |
7.372; 7.100; 6.534; 7.778; 5.413; 10.412 | — |
| SECONDARY Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 |
9.096; 7.249; 9.749; 5.686; 5.569; 9.857 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24 |
11.014; 8.63; 10.884; 9.389; 6.381; 12.446 | — |
| SECONDARY Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24 |
0.163; 1.79; 19.9; 32.1; 0.122; 1.64 | — |
| SECONDARY Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24 |
26.9; 29.2; 27.7; 28.9; 28.9; 166 | — |
| SECONDARY Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response |
9; 16; 31; 33; 13; 89 | — |
| SECONDARY Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity |
21; 28; 23; 20; 20; 15 | — |
| SECONDARY Number of Treatment-emergent Adverse Events by Severity |
66; 78; 66; 56; 49; 34 | — |
| SECONDARY Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events |
26; 25; 26; 25; 18 | — |
| SECONDARY Number of Treatment-related Treatment-emergent Adverse Events |
55; 52; 46; 47; 21 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02309359). 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.