HZN-825 for Systemic Sclerosis

Recruiting at 167 trial locations

Overseen By HorizonTherapeutics

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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

301 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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).

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• HZN-825

Trial Overview The 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.

How Is the Trial Designed?

Group I: HZN-825 300 mg twice daily (BID) Experimental Treatment 1 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 Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

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

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Horizon Therapeutics Ireland DAC

Lead Sponsor

Trials

21

Recruited

2,500+