Clin2
NCT06647069Possibly a fitRecruiting

Testing a new drug for lupus and rheumatoid arthritis

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

Part of Bones, joints & muscles, Immune system & allergy, Skin clinical trials.

This study tests an investigational drug called SAR448501/DR-0201 in people with active lupus or rheumatoid arthritis who have not responded well to standard treatments. The goal is to see if the drug is safe and helps control disease activity.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
62 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • You must have either systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA), diagnosed by standard criteria.
  • For lupus: Your disease must be moderately to severely active, with a score of at least 8 on a standard activity scale, and you must have had a poor response to at least one treatment besides antimalarials.
  • For rheumatoid arthritis: Your disease must be moderate to severe (based on joint counts and a disease activity score), and you must have tried and failed or not tolerated at least 2 prior drugs, including at least one biologic or targeted synthetic drug.
  • You must use effective birth control during and for at least 140 days after the last dose. Women must have a negative pregnancy test before starting.
  • You cannot have certain other serious health conditions, active infections, or have received certain strong medications or procedures within specific timeframes.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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