Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04478994

A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Diffuse Cutaneous Systemic Sclerosis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis

Clinical Trial Summary

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 (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody (mAb) inhibitor of the IGF-1 receptor (IGF-1R), administered once every 3 weeks (q3W) for 24 weeks in the treatment of participants with diffuse cutaneous systemic sclerosis (dcSSc).

Clinical Trial Description

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 inquire how the participant is doing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04478994
Study type Interventional
Source Horizon Pharma USA, Inc.
Contact
Status Terminated
Phase Phase 1
Start date November 17, 2021
Completion date December 8, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT02161406 - A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis Phase 2
Completed NCT03222492 - Brentuximab Vedotin for Systemic Sclerosis Phase 1/Phase 2
Completed NCT04137224 - Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) Phase 2
Not yet recruiting NCT04986605 - Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis Phase 2
Completed NCT02503644 - Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis Phase 2
Recruiting NCT04781543 - A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis Phase 2
Enrolling by invitation NCT05626751 - An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc) Phase 2
Withdrawn NCT05098145 - A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis Phase 1/Phase 2
Completed NCT03198689 - Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis Phase 2
Terminated NCT04680975 - Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis Phase 2
Completed NCT00433186 - Mycophenolate Mofetil in Systemic Sclerosis Phase 1
Terminated NCT03919799 - KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis Phase 2
Not yet recruiting NCT06152172 - CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 Phase 1
Suspended NCT04166552 - Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis Phase 2
Not yet recruiting NCT06375005 - Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis Phase 2
Recruiting NCT05270668 - Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007) Phase 2
Recruiting NCT05168215 - Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.
Completed NCT04440592 - Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis Phase 2
Recruiting NCT05149768 - Open Label Extension Study of Brentuximab Vedotin in Early dcSSc Phase 2
Withdrawn NCT04138485 - Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc) Phase 2