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A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease

NCT06525506 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-10-03

No results posted yet for this study

Summary

This is a multicenter, randomized, double-masked phase II study evaluating the efficacy and safety of IBI311 in subjects with inactive or active thyroid eye disease. Approximately 36 subjects meeting the study eligibility criteria will be randomly assigned to the 3-10 mg group, 3-20 mg group, 10 mg group, or 20 mg group on day 1 in a 1:1:2:2 ratio. Dose conversion of the 3-10 mg or 3-20 mg group was performed at week 12. Active and inactive TED was a stratification factor in this study. Active and inactive TED subjects were enrolled in a 1:1 ratio.

Conditions

  • Thyroid Eye Disease

Interventions

BIOLOGICAL

IBI311 (20 mg)

Arm 4: 10 mg/kg IBI311 on Day 1, followed by 20 mg/kg IBI311 from week 3 to week 21, Q3W.

BIOLOGICAL

IBI311 (3-20 mg)

Arm 2: 3 mg/kg IBI311 from day 1 to week 9, Q3W, followed by 20 mg/kg IBI311 from week 12 to week 21, Q3W.

BIOLOGICAL

IBI311 (10 mg)

Arm 3: 10 mg/kg IBI311 from day 1 to week 21, Q3W.

BIOLOGICAL

IBI311 (3-10mg/kg)

Arm 1: 3 mg/kg IBI311 from day 1 to week 9, Q3W, followed by 10 mg/kg IBI311 from week 12 to week 21, Q3W.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2025-01-09
Completion
2025-09-22

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 NCT06525506 on ClinicalTrials.gov