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

Ablynx

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Other: Placebo; Drug: Methotrexate; Biological: ALX-0061

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309359

2014-003033-26 (EudraCT Number)

ALX0061-C201

Details and patient eligibility

About

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.

Full description

Subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201 were invited to participate in an open-label extension (OLE) study ALX0061-C203 (NCT02518620), if the study was approved in their country and selection criteria were met.

Enrollment: 345 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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345 participants in 5 patient groups, including a placebo group

Placebo q2w + MTX

Placebo Comparator group

Description:

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Treatment:

Other: Placebo

Drug: Methotrexate

ALX-0061 75 mg q4w + MTX

Experimental group

Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Treatment:

Biological: ALX-0061

Other: Placebo

Drug: Methotrexate

ALX-0061 150 mg q4w + MTX

Experimental group

Description:

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Treatment:

Biological: ALX-0061

Other: Placebo

Drug: Methotrexate

ALX-0061 150 mg q2w + MTX

Experimental group

Description:

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Treatment:

Biological: ALX-0061

Other: Placebo

Drug: Methotrexate

ALX-0061 225 mg q2w + MTX

Experimental group

Description:

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Treatment:

Biological: ALX-0061

Drug: Methotrexate