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A Study of IBI311 in Subjects With Active Thyroid Eye Disease

Primary Purpose

Thyroid Eye Disease

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IBI311
placebo
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Eye Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: 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. Key Exclusion Criteria: 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;

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

IBI311

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The overall responder rate in the study eye.
Responder rate were defined as participants with a reduction in clinical activity score (CAS, see Secondary Outcome Measure 2 description for details) of ≥ 2 points, and a reduction in proptosis of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye.)
Percentage of subjects with a CAS value of 0 or 1 in the study eye.
According to the 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amendment, CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.
Mean Change of the CAS value in the study eye.
Mean change from Baseline in proptosis measurement in the study eye.
proptosis measurement: see Primary Outcome Measure 1 description for details
The proptosis responder rate of the study eye.
proptosis responder rate: see Primary Outcome Measure 1 description for details
The diplopia responder rate of the study eye.

Full Information

First Posted
March 6, 2023
Last Updated
October 16, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05795621
Brief Title
A Study of IBI311 in Subjects With Active Thyroid Eye Disease
Official Title
A Multicenter, Randomized, Double-masked, Placebo-controlled Phase II/III Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Active Thyroid Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
June 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
IBI311
Arm Type
Active Comparator
Arm Description
Participants with TED will be randomized to receive 4/8 intravenous infusions of IBI311 with an interval of 3 weeks for phase II/III.
Intervention Type
Biological
Intervention Name(s)
IBI311
Intervention Description
10 mg/kg on Day 1 followed by 20 mg/kg q3W for the remaining 7 infusions for phase II/III.
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
4 does of placebo for phase II; 8 does of placebo for phase III.
Primary Outcome Measure Information:
Title
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).
Description
proptosis assessment: amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer
Time Frame
Week 12 for phase II, Week 24 for phase III
Secondary Outcome Measure Information:
Title
The overall responder rate in the study eye.
Description
Responder rate were defined as participants with a reduction in clinical activity score (CAS, see Secondary Outcome Measure 2 description for details) of ≥ 2 points, and a reduction in proptosis of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye.)
Time Frame
Week12 and Week24 for phase II, Week 24 for phase III
Title
Percentage of subjects with a CAS value of 0 or 1 in the study eye.
Description
According to the 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amendment, CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.
Time Frame
Week12 and Week24 for phase II, Week 24 for phase III
Title
Mean Change of the CAS value in the study eye.
Time Frame
Baseline to Week 12 and Week 24 for phase II
Title
Mean change from Baseline in proptosis measurement in the study eye.
Description
proptosis measurement: see Primary Outcome Measure 1 description for details
Time Frame
Baseline to Week 12 and Week 24 for phase II, Baseline to Week 24 for phase III
Title
The proptosis responder rate of the study eye.
Description
proptosis responder rate: see Primary Outcome Measure 1 description for details
Time Frame
Week 24 for phase II
Title
The diplopia responder rate of the study eye.
Time Frame
Week12 and Week24 for phase II, Week 24 for phase III

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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;
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of IBI311 in Subjects With Active Thyroid Eye Disease

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