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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 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 174 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05626751
The ClinicalTrials.gov registry entry for NCT05626751 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HZN-825 is the first listed.
NCT05626751 reports 0 study locations.
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.
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