TerminatedPhase 2

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Stopped: The study was not stopped due to safety reasons

United States174 participantsStarted 2022-11-04

Plain-language summary

Primary Objectives: 1. 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 sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Anticipated use of another investigational agent for any condition during the course of the trial.
✕. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
✕. Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol.
✕. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.
✕. Pregnant or lactating women.
✕. Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.

What they're measuring

Change From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52

Timeframe: Baseline and Week 52

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Timeframe: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

Number of Participants Who Experienced AEs of Special Interest (AESI)

Timeframe: Day 1 and at Weeks 4, 28 and 52

Number of Participants Using Any Concomitant Medication

Timeframe: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

Trial details

NCT IDNCT05626751

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-24

Results submitted2025-12-12

View on ClinicalTrials.gov More Diffuse Cutaneous Systemic Sclerosis trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Anticipated use of another investigational agent for any condition during the course of the trial.
✕. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
✕. Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol.
✕. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.
✕. Pregnant or lactating women.
✕. Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.

What they're measuring

Change From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52

Timeframe: Baseline and Week 52

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Timeframe: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

Number of Participants Who Experienced AEs of Special Interest (AESI)

Timeframe: Day 1 and at Weeks 4, 28 and 52

Number of Participants Using Any Concomitant Medication

Timeframe: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months