The overall
objective is to investigate the safety, tolerability and effect on
insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of
TEPEZZA®
administered once every 3 weeks (q3W) for 24 weeks in the treatment of
participants with diffuse cutaneous systemic sclerosis (dcSSc).
This is
a randomized, double-blind, placebo-controlled, repeat-dose, multicenter
study. Participants will be screened for the study within 4 weeks prior to the
Baseline (Day 1) Visit. Approximately 25 participants who meet the study
eligibility criteria will be randomized on Day 1 in a 3:2 ratio to receive 8
infusions of TEPEZZA® or placebo q3W. During the 24-week double-blind Treatment
Period, study drug will be infused on Day 1 (Baseline) and Weeks 3, 6, 9, 12,
15, 18 and 21 with a comprehensive visit at Week 24 (end of treatment). On
each dosing day, scheduled assessments (except for Adverse Events [AE] and
concomitant medication use monitoring, which will be monitored throughout the
clinic visit) will be completed prior to study drug infusions. At the end of
the Treatment Period (Week 24), participants will enter a 24-week Follow-up
Period, during which study drug will not be administered and a clinic visit
will be scheduled for Weeks 28, 36 and 48. A phone call or email at Weeks 32 and 42 will
occur to follow-up with each participant.
| Condition | Diffuse Cutaneous Systemic Sclerosis |
|---|---|
| Treatment | Placebo, TEPEZZA |
| Clinical Study Identifier | NCT04478994 |
| Sponsor | Horizon Therapeutics USA, Inc. |
| Last Modified on | 31 May 2023 |
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