This study is in progress, not accepting new patients

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

a study on Diffuse Scleroderma Systemic Sclerosis

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Elizabeth Volkmann (ucla)

Description

Summary

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 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 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in 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, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

Official Title

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Details

Acquired from Horizon in 2024.

Keywords

Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic, Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Sclerosis, HZN-825 BID, HZN-825 QD

Eligibility

You can join if…

Open to people ages 18-75

  1. Written informed consent.
  2. Male or female between the ages of 18 and 75 years, inclusive, at Screening.
  3. 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).
  4. Classified as having skin involvement proximal to the elbow and knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
  5. At the time of enrollment, less than or equal to 72 months (6 years) since the onset of the first SSc manifestation, other than Raynaud's phenomenon.
  6. Skin thickening from SSc in the forearm suitable for repeat biopsy.
  7. mRSS units ≥15 at Screening.
  8. FVC ≥45% predicted at Screening, as determined by spirometry.
  9. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.

You CAN'T join if...

  1. Positive for anti-centromere antibodies with the exception that subjects who are positive for both anti-centromere and anti-topoi

Locations

  • UCLA Rheumatology
    Los Angeles California 90024-2704 United States
  • UCLA Department of Medicine
    Los Angeles California 90095-1670 United States
  • The Southern California Scleroderma and Rheumatology Center
    Inglewood California 90301 United States
  • Stanford University School of Medicine
    Stanford California 94305-2200 United States

Lead Scientist at University of California Health

  • Elizabeth Volkmann (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 117 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT04781543
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 301 people participating
Last Updated