A Multicenter Trial to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

  • STATUS
    Recruiting
  • End date
    Jul 23, 2023
  • participants needed
    300
  • sponsor
    Horizon Therapeutics Ireland DAC
Updated on 23 July 2021
diffuse cutaneous systemic sclerosis

Summary

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks.

The trial will include up to a 4-week Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT not available yet). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

Details
Condition Scleroderma, Systemic sclerosis, Diffuse Scleroderma, diffuse cutaneous systemic sclerosis
Treatment Placebo, HZN-825 BID, HZN-825 QD
Clinical Study IdentifierNCT04781543
SponsorHorizon Therapeutics Ireland DAC
Last Modified on23 July 2021

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