A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02287922

Run by

Ablynx, a Sanofi company

People needed

251

Starts

2015-03-01

Expected to finish

2016-07-01

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigator Site — Hemet, California, United States
• Investigator Site — La Palma, California, United States
• Investigator site — Los Angeles, California, United States
• Investigator Site — Los Angeles, California, United States
• Investigator site — Ventura, California, United States
• Investigator site — Hialeah, Florida, United States
• Investigator Site — Homestead, Florida, United States
• Investigator Site — Orlando, Florida, United States
• Investigator Site — Stockbridge, Georgia, United States
• Investigator site — Overland Park, Kansas, United States
• Investigator Site — Worcester, Massachusetts, United States
• Investigator Site — Albuquerque, New Mexico, United States
• Investigator Site — New York, New York, United States
• Investigator Site — Charleston, South Carolina, United States
• Investigator Site — Memphis, Tennessee, United States
• Investigator Site — Mesquite, Texas, United States
• Investigator Site — Brussels, Belgium
• Investigator Site — Ghent, Belgium
• Investigator Site — Liège, Belgium
• Investigator Site — Burgas, Bulgaria
• Investigator Site — Pleven, Bulgaria
• Investigator Site 1 — Plovdiv, Bulgaria
• Investigator Site 2 — Plovdiv, Bulgaria
• Investigator Site 1 — Rousse, Bulgaria
• Investigator Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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