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A Study of IBI311 in Subjects With Active Thyroid Eye Disease

NCT05795621 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2024-02-08

No results posted yet for this study

Summary

This is a multicenter, randomized, double-masked, placebo-controlled Phase II/III study in subjects with active thyroid eye disease. Approximately 114 subjects meeting study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by smoking status

Conditions

  • Thyroid Eye Disease

Interventions

BIOLOGICAL

IBI311

10 mg/kg on Day 1 followed by 20 mg/kg q3W for the remaining 7 infusions for phase II/III.

BIOLOGICAL

placebo

4 does of placebo for phase II; 8 does of placebo for phase III.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-12-20
Completion
2023-12-20

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT05795621 on ClinicalTrials.gov