Lead Sponsor

Ablynx, a Sanofi company

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

No

•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

•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.

Related studies

NCT07536529 · Inflammatory Joint Diseases, Rheumatoid Arthritis (RA), and more

NCT06329401 · Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, and more

NCT07048197 · Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)

NCT07484243 · Rheumatoid Arthritis (RA), Rheumatoid Arthritis-Associated Interstitial Lung Disease, and more

NCT06647069 · Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)

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