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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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.

Exclusion Criteria

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HZN-825 300 mg once daily (QD) 		One set of 2 HZN-825 150mg tablets in the morning and one set of 2 placebo tablets in the evening.
  • Drug: HZN-825 QD
    300 mg oral tablets QD
Experimental
HZN-825 300 mg twice daily (BID) 		One set of 2 HZN-825 150mg tablets in the morning and one set of 2 HZN-825 150mg tablets in the evening.
  • Drug: HZN-825 BID
    300 mg oral tablets BID
Placebo Comparator
Placebo 		One set of 2 placebo tablets in the morning and one set of 2 placebo tablets in the evening.
  • Drug: Placebo
    Placebo BID

More Details

Status
Active, not recruiting
Sponsor
Amgen

Study Contact

Detailed Description

Acquired from Horizon in 2024.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.