MARASLE

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Subcutaneous Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus (MARASLE)

• IRAS ID

  1008301

• Contact name

  ERIC Zollars

• Contact email

  eric.zollars@gilead.com

• Sponsor organisation

  Gilead Sciences Inc.

• Research summary

  Study Design:
  This is a Phase 1b, randomised, sponsor-unblinded (Patients and doctor don't know if a patient will receive placebo or new medication), placebo-controlled, multiple-cohort study to evaluate the safety, tolerability including how the body interacts and reacts to the new medication called GS-0272 and what reaction the drug is causing in different concentrations in human body including an immune-response.
  in participants with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). The study
  will consist of 2 parts as follows:
  Part A (RA )
  Part A is for patients with rheumatoid arthritis, they will be given multiple injections under the skin of GS-0272/ placebo in different doses, upon review and approval by a Safety Review Team (SRT)/dose escalation team the dose of medication given to patients will increase to next patient group, three cohorts are planned. Each cohort will consist of 8 eligible participants randomised in a 3:1 ratio to receive
  either GS-0272 (6 participants) or placebo (2 participants) every 2 weeks (Q2W) for 12 weeks.

  Part B (SLE)
  Part B will be similar to Part A but for participants with SLE. The cohort may be initiated in parallel with the highest-dose cohort (last group) in Part A, following dose escalation review and approval to proceed. The cohort will consist of 12 eligible participants randomised in a 3:1 ratio to receive either GS-0272 (9 participants) or placebo (3 participants) every 2 weeks for 12 weeks.

  The study will consist of 3 periods: screening (up to 29 days), treatment period (12 weeks), and follow-up (up to 16 weeks).
  Number of Participants Planned: Up to 48 participants total (up to 36 participants in Part A
  [RA] and 12 participants in Part B [SLE]). The Participants will then be followed up for 16 weeks.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  23/WM/0185

• Date of REC Opinion

  30 Oct 2023

• REC opinion

  Further Information Favourable Opinion