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NCT05626751 · ClinicalTrials.gov registry record · Phase 2
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
A Phase 2 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
NCT05626751: Clinical Trial Phase 2 study, sponsored by Amgen.
NCT05626751 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 174 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05626751, a Phase 2 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
Study 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.
Primary Outcome
FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. FVC is a measure of respiratory function. FVC% predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.
Interventions
- DRUG HZN-825
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2022-11-04 |
| Est. Completion | 2025-02-24 |
| Phase | Phase 2 |
Why NCT05626751 stopped before completion
NCT05626751 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 1 intervention - of which HZN-825 is the first listed.
NCT05626751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05626751 about?
NCT05626751 is a clinical study titled "An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)". 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 sa...
What is the current status of trial NCT05626751?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2022-11-04. Estimated completion is 2025-02-24.
What interventions are being tested in trial NCT05626751?
The interventions under investigation include: HZN-825 (DRUG).
Who is sponsoring clinical trial NCT05626751?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05626751's enrollment target sits among peer trials
174 396th of 2000 higher than 1,604 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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