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Compensation: Varies

Number of Visits: 11

301 Participants Needed

HZN-825 for Systemic Sclerosis

Recruiting at 167 trial locations

Overseen ByHorizonTherapeutics

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Amgen

Must be taking: CellCept, Myfortic, Methotrexate

Must not be taking: Rituximab, Antidepressants

Disqualifiers: HIV, Hepatitis, Cancer, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Research Team

Principal Investigator

Amgen

Eligibility Criteria

This trial is for adults aged 18-75 with diffuse cutaneous systemic sclerosis, a skin condition causing thickening and hardening. Participants must have certain severity scores, no recent severe heart issues or organ transplants, stable medication use if applicable, and agree to birth control measures. Those with specific infections or other autoimmune diseases are excluded.

Inclusion Criteria

mRSS units ≥15 at Screening.

Written informed consent.

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).

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Exclusion Criteria

I haven't taken strong immune-suppressing drugs, except for allowed ones at low doses, in the last 4 weeks.

I haven't had cancer in the past 5 years, except for certain skin or cervical cancers.

I agree to use effective birth control during and for 1 month after the trial.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

1 visit (in-person)

Double-blind Treatment

Participants receive HZN-825 or placebo for 52 weeks, with visits at Week 4 and every 6 weeks thereafter

52 weeks

9 visits (in-person)

Safety Follow-up

Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug

4 weeks

1 visit (in-person)

Extension

Participants who complete the Double-blind Treatment Period are eligible to enter a 52-week extension trial

52 weeks

Treatment Details

Interventions

HZN-825

Trial OverviewThe study tests HZN-825 taken once (QD) or twice daily (BID) against a placebo over 52 weeks to assess its effectiveness in treating systemic sclerosis. It's randomized and double-blind, meaning neither the participants nor the researchers know who receives the actual drug versus placebo.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: HZN-825 300 mg twice daily (BID)Experimental Treatment1 Intervention

One set of 2 HZN-825 150mg tablets in the morning and one set of 2 HZN-825 150mg tablets in the evening.

Group II: HZN-825 300 mg once daily (QD)Experimental Treatment1 Intervention

One set of 2 HZN-825 150mg tablets in the morning and one set of 2 placebo tablets in the evening.

Group III: PlaceboPlacebo Group1 Intervention

One set of 2 placebo tablets in the morning and one set of 2 placebo tablets in the evening.

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Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

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