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Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients

NCT05394857 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-12-27

No results posted yet for this study

Summary

This is a single-arm, prospective, open-label, Phase II study that explored the efficacy and safety of SHR-1314 in active moderate to severe Graves' Orbitopathy. The study consists of a 6-week screening period, a 16-week treatment period, and a 12-week follow-up period. Eighteen adult patients with active moderate to severe Graves' Orbitopathy will be enrolled. Eligible subjects will receive SHR-1314 subcutaneously. The primary endpoint was the proptosis responder rate and will be evaluated at 16weeks.

Conditions

  • Active Moderate to Severe Graves' Orbitopathy

Interventions

DRUG

SHR-1314

SHR-1314 subcutaneously

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2023-08-22
Completion
2023-08-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394857 on ClinicalTrials.gov