A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-82… (NCT04781543) | Clinical Trial Compass
TerminatedPhase 2
A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis
Stopped: The study was terminated due to meeting pre-defined criteria for futility.
Serbia, Spain301 participantsStarted 2021-11-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Written informed consent.
✓. Male or female between the ages of 18 and 75 years, inclusive, at Screening.
✓. Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc with a total score of ≥9 (Van den Hoogen et al., 2013).
✓. Classified as having skin involvement proximal to the elbow and knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
✓. At the time of enrollment, less than or equal to 72 months (6 years) since the onset of the first SSc manifestation, other than Raynaud's phenomenon.
✓. Skin thickening from SSc in the forearm suitable for repeat biopsy.
✓. mRSS units ≥15 at Screening.
✓. FVC ≥45% predicted at Screening, as determined by spirometry.
Exclusion criteria
✕. Positive for anti-centromere antibodies with the exception that subjects who are positive for both anti-centromere and anti-topoisomerase 1 antibodies may be enrolled.
What they're measuring
1
Change From Baseline in Forced Vital Capacity Percent (FVC%) Predicted at Week 52
✕. Diagnosed with sine scleroderma or limited cutaneous SSc.
✕. Diagnosed with other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren's syndrome.
✕. Scleroderma renal crisis diagnosed within 6 months of the Screening Visit.
✕. Any of the following cardiovascular diseases:
✕. uncontrolled, severe hypertension (≥160/100 mmHg) or persistent low blood pressure (systolic blood pressure \<90 mmHg) within 6 months of Screening,
✕. myocardial infarction within 6 months of Screening,
✕. unstable cardiac angina within 6 months of Screening.