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

Phase 1

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of trial drug up to week 24

Summary

This trial is testing TEPEZZA, a medicine that blocks a protein causing inflammation and scarring, in patients with a skin condition called diffuse cutaneous systemic sclerosis. The study will see if TEPEZZA is safe and effective when given over several months. The goal is to find out if it can help reduce symptoms in these patients.

Eligible Conditions

Scleroderma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of trial drug up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of trial drug up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of trial drug up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TEPEZZA 20mg/kgActive Control1 Intervention

Approximately 15 participants will receive 8 infusions of TEPEZZA q3W for a total of 21 weeks. TEPEZZA 10mg/kg will be administered on Day 1 and TEPEZZA 20mg/kg will be administered q3W for the remaining 7 infusions.

Group II: PlaceboPlacebo Group1 Intervention

Approximately 10 participants will receive 8 infusions of placebo q3W for a total of 21 weeks.

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