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Monoclonal Antibodies

TEPEZZA for Systemic Sclerosis

Phase 1
Recruiting
Research Sponsored by Horizon Therapeutics USA, Inc.
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
Awards & highlights

Study Summary

This trial is testing a new drug for safety, tolerability and effectiveness in treating people with a connective tissue disease.

Eligible Conditions
  • Systemic Sclerosis

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Find a Location

Who is running the clinical trial?

Horizon Therapeutics USA, Inc.Lead Sponsor
3 Previous Clinical Trials
391 Total Patients Enrolled
Study DirectorStudy DirectorHorizon Therapeutics USA, Inc.
1,215 Previous Clinical Trials
499,589 Total Patients Enrolled
Thomas Vescio, MDStudy DirectorHorizon Therapeutics USA, Inc.
1 Previous Clinical Trials
62 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers are hosting this research endeavor?

"The trial is currently running onsite at The Johns Hopkins Bayview Medical Center in Baltimore, MD, Pacific Arthritis Care Center in Los Angeles, CA and UCLA Division of Rheumatology in Cleveland, TX as well as other 10 locations."

Answered by AI

Might I be qualified to partake in this clinical experiment?

"To qualify for this research project, scleroderma patients must fall between the age of 18 and 80. The team is currently looking to recruit 25 individuals into their study."

Answered by AI

Does this trial represent a pioneering exploration in the field?

"Research into TEPEZZA began in 2021 and was sponsored by Horizon Therapeutics USA, Inc. A Phase 4 drug approval followed the initial trial of 62 that year. Presently, it is being trialled across 6 countries with 27 cities hosting active clinical studies."

Answered by AI

How likely is it for TEPEZZA to cause adverse effects in people?

"As TEPEZZA is still in its initial clinical trial phase, our team at Power has assessed the safety of this medication to be a 1 due to limited evidence backing up efficacy and security."

Answered by AI

What is the aggregate population size of participants in this investigation?

"Affirmative. The information available on clinicaltrials.gov infers that this medical research, originally posted on November 17th 2021, is currently recruiting patients for the study. 25 individuals are needed to be recruited at 10 distinct medical sites."

Answered by AI

Are there any additional investigations regarding TEPEZZA?

"TEPEZZA was first investigated at Kahana Oculoplastic and Orbital Surgery in 2021. Since then, 18332 studies have been officially concluded; currently there are 3 trials ongoing, many of these situated near Baltimore Maryland."

Answered by AI

Is this research endeavor actively seeking participants?

"Affirmative. According to records on clinicaltrials.gov, this trial has been recruiting since November 17th 2021 and its most recent update was made on March 22nd 2022; the goal is to gather 25 volunteers at 10 distinct sites."

Answered by AI

Are septuagenarians eligible for this investigation?

"This research endeavour seeks participants aged 18 or above and below 80 years old."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
The Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
2021. "A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04478994.
All > Scleroderma Research Foundation
~7 spots leftby May 2025
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