BEACON OLE
Research type
Research Study
Full title
A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis
IRAS ID
1006812
Contact name
Farah Ali
Contact email
Sponsor organisation
Horizon Therapeutics Ireland DAC
Eudract number
2021-006271-42
Clinicaltrials.gov Identifier
Research summary
This is an open-label, repeat-dose, multicenter extension trial of HZNP-HZN-825-301. Subjects who complete the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301 will be eligible to enter this 52-week extension trial. Subjects entering this extension trial will complete the Week 52 Visit activities in HZNP-HZN-825-301 and will not complete the Safety Follow-up Visit 4 weeks after the last dose of trial drug in HZNP-HZN-825-301.
On Day 1 (Week 52 Visit of HZNP-HZN-825-301), subjects will receive their first dose of HZN-825 in this extension trial at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. The Week 52 Visit activities in HZNP-HZN-825-301 will serve as Trial Baseline for this extension trial.
If a subject prematurely discontinues trial drug, he/she will be asked to remain in the trial, participating in the scheduled trial visits through Week 52. If a subject prematurely discontinues trial drug and does not wish to continue in the trial, he/she will return for a clinic visit and undergo the Week 52 assessments. Subjects will participate in a Safety Follow-up Visit 4 weeks after the last dose of HZN-825.
The dose regimen for all subjects will be HZN-825 300 mg BID. Subjects will take 2 HZN-825 150 mg tablets orally in the morning and evening with a meal.
Study procedures include vital signs, physical examination, questionnaires, High-Resolution CT scans, ECGs, blood and urine samples. Please refer to the protocol for a comprehensive list of all study procedures.
The study is sponsored by Horizon Therapeutics Ireland DAC.
REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0805
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion