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Thyroid Eye DiseasePhase 2/3NCT05795621

A Study of IBI311 in Subjects With Active Thyroid Eye Disease

A Phase 2/3 study testing IBI311 in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Thyroid Eye Disease
What is being tested?
IBI311
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
1 siteChina
Study dates
14 Feb 2023to 20 Dec 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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

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

Being tested
IBI311, placebo
Medical subject headings
Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI311Biological

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

  • placeboBiological

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

Study groups in NCT05795621
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Biological: IBI311; Biological: placebo
IBI311Active comparatorParticipants with TED will be randomized to receive 4/8 intravenous infusions of IBI311 with an interval of 3 weeks for phase II/III.
Receives: Biological: IBI311

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 12 for phase II, Week 24 for phase III

Secondary outcomes (6)

  1. 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.)

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

  2. 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.

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

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

    Measured: Baseline to Week 12 and Week 24 for phase II

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

    proptosis measurement: see Primary Outcome Measure 1 description for details

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

  5. The proptosis responder rate of the study eye.

    proptosis responder rate: see Primary Outcome Measure 1 description for details

    Measured: Week 24 for phase II

  6. The diplopia responder rate of the study eye.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start14 Feb 2023
  3. Primary completion20 Dec 2023
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05795621
Sponsor's protocol ID
CIBI311A201
Status last verified
Feb 2024
First submitted
6 Mar 2023
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41066129

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing IBI311 in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Week 12 for phase II, Week 24 for phase III). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795621, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

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