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 trial explores the effects of HZN-825, a potential new treatment for systemic sclerosis, a disease that causes the hardening and tightening of skin and organs. Researchers will compare two different daily doses of HZN-825 to a placebo to determine if it can improve symptoms over a year. Individuals with systemic sclerosis for 6 years or less and noticeable skin involvement may be suitable for this trial. Participants will attend regular check-ups to monitor progress and safety. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Is there any evidence suggesting that HZN-825 is likely to be safe for humans?

Research has shown that HZN-825 has undergone previous testing to ensure its safety for humans. In earlier studies with patients who have diffuse cutaneous systemic sclerosis (a condition that thickens and hardens the skin), the treatment proved safe. Most patients tolerated HZN-825 well.

In those studies, some participants experienced mild side effects, but no serious safety issues arose. The trial's later stage indicates sufficient safety information exists to test it in more people, confirming HZN-825's safety in earlier studies.

For those considering joining a trial, this is promising news about the treatment's safety. However, discussing this with a doctor is crucial to understand its implications personally. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for systemic sclerosis?

Researchers are excited about HZN-825 for systemic sclerosis because it offers a new approach by targeting the lysophosphatidic acid (LPA) receptor 1, which is different from current treatments like immunosuppressants and anti-inflammatory drugs. This unique mechanism of action may help modulate the fibrotic process central to systemic sclerosis, potentially offering better management of symptoms and disease progression. Additionally, HZN-825 is being tested in two dosing regimens, once daily and twice daily, to explore the most effective way to reduce fibrosis with minimal side effects.

What evidence suggests that HZN-825 might be an effective treatment for systemic sclerosis?

Research suggests that HZN-825 might help treat systemic sclerosis. In an earlier study, HZN-825 improved symptoms in diffuse cutaneous systemic sclerosis, a specific type of this condition. The treatment blocks a receptor called LPAR1, which contributes to scar-like tissue development, a major issue in systemic sclerosis. Early trials showed that patients tolerated the treatment well, indicating potential safety. Although the results are promising, further research is necessary to confirm these findings. This trial will evaluate different dosing regimens of HZN-825, including 300 mg once daily and 300 mg twice daily, to further assess its effectiveness and safety. ^{1 2 3 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04781543

NCT04781543 | A Multicenter Trial to Evaluate the Efficacy ... A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05626751

An Open-label Extension Trial of HZNP-HZN-825-301 in ... The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic ...

3. horizonscandb.pcori.org horizonscandb.pcori.org/report/topics/628

Fipaxalparant (AMG 670) to treat diffuse cutaneous ... Fipaxalparant (formerly AMG 670/HZN-825) is an oral small-molecule drug under clinical development to treat diffuse cutaneous systemic sclerosis.

4. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-006271-42/PT

Clinical Trials Register The overall objective is to investigate the efficacy, safety and tolerability of HZN-825, a selective antagonist of LPAR1, administered BID ...

5. biospace.com biospace.com/horizon-therapeutics-plc-announces-first-patient-enrolled-in-phase-2b-pivotal-trial-evaluating-hzn-825-for-the-treatment-of-diffuse-cutaneous-systemic-sclerosis

Horizon Therapeutics plc Announces First Patient Enrolled ... The placebo-controlled 8-week trial of HZN-825 in diffuse cutaneous systemic sclerosis, completed in 2018, showed a positive trend in response, ...

6. youtube.com youtube.com/watch?v=P30kbEWFlfY

Phase 2b Trial Testing HZN-825 to Treat Diffuse Cutaneous ... of HZN-825, to treat patients with diffuse cutaneous systemic sclerosis (dcSSc) ... safety data in a Phase 2a trial in patients with early dcSSc.

7. mayo.edu mayo.edu/research/clinical-trials/cls-20567118

An Open-label Extension Trial of HZNP-HZN-825-301 in ... The purpose of this study is treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis.