Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors.

A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222447

Enrollment

140

Registered

2014-04-01

Start date

2014-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : Clazakizumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Inadequate responders to TNF inhibitors. -All subjects must have been receiving treatment with a minimum dose of 7.5 mg per week of methotrexate for at least 12 weeks and at a stable dose for 4 weeks prior to screening. -ACR global functional status class of 1 to 3. -Minimum of 6 swollen and 6 tender joints on a 66/68 joint count. -High sensitivity C-reactive protein (hsCRP) 0.8 mg/dL and above.

Exclusion criteria

Exclusion criteria: Subjects who have ever received tocilizumab or any investigational IL-6 inhibitor.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of clazakizumab versus placebo on a background of methotrexate as assessed by change from baseline in DAS28-CRP at 12 weeks.	—

Secondary

Measure	Time frame
Assess the efficacy of clazakizumab on a background of methotrexate in reducing signs and symptoms of rheumatoid arthritis by measures such as ACR rates, remission rates, and DAS28-CRP less than 2.6, over 12 weeks of treatment. Assess the efficacy of clazakizumab on a background of methotrexate in improving physical function as determined by change from baseline in HAQ-DI at 12 weeks of treatment. Assess the safety of clazakizumab on a background of methotrexate by assessment of Adverse Events (AEs) and laboratory parameters. Characterize the pharmacokinetics, immunogenicity, pharmacodynamics and biomarker responses of different clazakizumab doses on a background of methotrexate.	—

Measure

Time frame

Assess the efficacy of clazakizumab on a background of methotrexate in reducing signs and symptoms of rheumatoid arthritis by measures such as ACR rates, remission rates, and DAS28-CRP less than 2.6, over 12 weeks of treatment. Assess the efficacy of clazakizumab on a background of methotrexate in improving physical function as determined by change from baseline in HAQ-DI at 12 weeks of treatment. Assess the safety of clazakizumab on a background of methotrexate by assessment of Adverse Events (AEs) and laboratory parameters. Characterize the pharmacokinetics, immunogenicity, pharmacodynamics and biomarker responses of different clazakizumab doses on a background of methotrexate.

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026