A Study of IBI311 in Subjects With Active Thyroid Eye Disease

NCT05795621 | Completed Phase 2

• 1 other identifier: CIBI311A201
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The proptosis responder rate of the study eye (defined as percentage of subjects with a ≥ 2mm reduction from Baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye).

  proptosis assessment: amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer

  Week 12 for phase II, Week 24 for phase III

Secondary Outcomes (6)

• The overall responder rate in the study eye.

  Week12 and Week24 for phase II, Week 24 for phase III

• Percentage of subjects with a CAS value of 0 or 1 in the study eye.

  Week12 and Week24 for phase II, Week 24 for phase III

• Mean Change of the CAS value in the study eye.

  Baseline to Week 12 and Week 24 for phase II

• Mean change from Baseline in proptosis measurement in the study eye.

  Baseline to Week 12 and Week 24 for phase II, Baseline to Week 24 for phase III

• The proptosis responder rate of the study eye.

  Week 24 for phase II

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants with TED will be randomized to receive 4 intravenous infusions of Placebo with an interval of 3 weeks for phase II and 8 intravenous infusions of Placebo with an interval of 3 weeks for phase III.

Biological: IBI311; Biological: placebo

IBI311

ACTIVE COMPARATOR

Participants with TED will be randomized to receive 4/8 intravenous infusions of IBI311 with an interval of 3 weeks for phase II/III.

Biological: IBI311

Interventions

IBI311 BIOLOGICAL

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

IBI311; Placebo

placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Male or female subject between the ages of 18 and 80 years, inclusive, at Screening.
• Weight between 45 and 100 kg (inclusive).
• Clinical diagnosis of Graves' disease associated with active TED with a CAS ≥ 3 for at least one eye at Screening and Baseline.
• Moderate-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with at least two of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
• Female Subjects should be fertile women who are sterile or have a negative blood pregnancy test during the screening period and who agree to take contraceptive measures within 120 days from the screening period to the last medication; Male subjects should agree to use contraception from the screening period to 120 days after the last dose.

You may not qualify if:

• Subjects will be ineligible for study participation if they meet any of the following criteria:
• At the time of screening, according to the subject's chief complaint or medical record, the time of first symptoms of active thyroid eye disease appeared in \> 270 days;
• Optimal corrected vision loss due to optic neuropathy, defined as two lines of vision loss due to optic neuropathy within the past 180 days, new visual field defects, or color vision impairment secondary to optic nerve involvement;
• Corneal ulcers with no relief after treatment were determined by the investigator;
• Baseline CAS decreased by more than 2 points compared with screening;
• At any time prior to baseline or during the study period planned to receive orbital radiation therapy or TED specific surgery, including orbital decompression, strabismus surgery, and eyelid retraction correction;
• Poor thyroid function control was defined as free triiodothyronine (FT3) or free tetriodothyronine (FT4) deviated more than 50% from the normal reference range of the local research center laboratory during screening;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Zhang H, Sun J, Li Y, Zhu L, Shan Z, Lu W, Shen J, Shi Y, Tao L, Jiang H, Ji L, Zhu Y, Gu H, Liu X, Sun B, Tian Y, Liu Q, Zhou J, Zhao H, Guan H, Zhu L, Wen J, Lu Y, Qiao J, Zhang W, Deng J, Lu S, Han-Zhang H, Qian L, Zhou H, Fan X. IGF-1R Inhibitor IBI311 for the Treatment of Active Thyroid Eye Disease in Chinese Patients: The RESTORE-1 Randomized Clinical Trial. JAMA Ophthalmol. 2025 Nov 1;143(11):964-971. doi: 10.1001/jamaophthalmol.2025.3350.

  PMID: 41066129 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: February 14, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)