NCT04781543

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

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Acquired from Horizon in 2024.

Conditions

• Diffuse Cutaneous Systemic Sclerosis
• Sclerosis, Systemic

Interventions

Type	Name	Description
DRUG	HZN-825 BID	300 mg oral tablets BID
DRUG	Placebo	Placebo BID
DRUG	HZN-825 QD	300 mg oral tablets QD

Timeline

• Start date: 2021-11-05
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2021-03-04
• Last updated: 2026-03-20
• Results posted: 2026-03-20

Locations

4 sites across 2 countries: Serbia, Spain

Regulatory

• FDA-regulated drug study