Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    300
  • sponsor
    Horizon Therapeutics Ireland DAC
Updated on 22 October 2022
rheumatism
raynaud's phenomenon
raynaud's syndrome
diffuse cutaneous systemic sclerosis
MRSS

Summary

The goal is to determine the efficacy, safety and tolerability for 300 patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc) assigned to either one of 2 dose regimens of HZN-825 (administered once daily (QD) or twice daily (BID)), or a placebo regimen for 52 weeks.

Participants who complete all study visits may be eligible to enter a 52-week extension study where all patients will receive active HZN-825. Participants not entering the extension will have a follow-up visit for a final safety evaluation.

Description

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). 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.

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. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP-HZN-825-302). 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 Diffuse Cutaneous Systemic Sclerosis, Systemic Sclerosis
Treatment Placebo, HZN-825 BID, HZN-825 QD
Clinical Study IdentifierNCT04781543
SponsorHorizon Therapeutics Ireland DAC
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc with a total score of ≥9 [Van den Hoogen et al., 2013]
At the time of enrollment, less than 36 months since the onset of the first SSc manifestation, other than Raynaud’s phenomenon
Classified as having skin involvement proximal to elbow and/or knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001)
mRSS units ≥15 at Screening

Exclusion Criteria

Any of the following cardiovascular diseases: a.) uncontrolled, severe hypertension (≥160/100 mmHg) or persistent low blood pressure (systolic blood pressure <90 mmHg) within 6 months of Screening; b.) myocardial infarction within 6 months of Screening; c.) unstable cardiac agina within 6 months of Screening
PAH by right heart catheterization requiring treatment with more than 1 oral PAH-approved therapy or any parenteral therapy. Treatment is allowed for erectile dysfunction and/or Raynaud’s phenomenon/digital ulcers
Women of childbearing potential or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug
Positive for anti-centromere antibodies
Diagnosed with sine scleroderma or limited cutaneous SSc
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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