Thyroid Associated OphthalmopathyPhase 3NCT06269393

A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy

A Phase 3 study testing IBI311 in people with Thyroid Associated Ophthalmopathy, run by Peking University People's Hospital 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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Thyroid Associated Ophthalmopathy
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: 53 participants
Where: 1 siteChina
Study dates: 1 Jan 2024to 3 Jul 2025
Phase: Phase 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 18 and 80 years (inclusive) at Screening.
Steroid-resistant TAO, defined as poor response to steroid after completing a 3-month steroid pulse therapy (4.5g to 8.0g methylprednisolone) or 3-6 months of oral glucocorticoids treatment (i.e., CAS decreased by < 2 points, or proptosis decreased by < 2mm, or no improvement in diplopia), or relapse of TAO after steroid withdrawal (CAS increased by ≥2 points and CAS≥3 points [7-item scale] in either eye, or proptosis increased by ≥2 mm, or Gorman diplopia score increased by ≥1 point).
Moderate-to-severe active TAO or chronic TAO at screening:
Inclusion criteria for subjects with moderate-to-severe active TAO:
Active TAO, with CAS ≥3 in the study eye during the screening period;

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Proptosis ≥18 mm in the study eye;
Moderate to severe active TAO, usually associated with at least two of the following manifestations: eyelid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above upper limit of normal (ULN), inconstant or constant diplopia (Gorman subjective diplopia score 2-3);
CAS ≤2 in both eyes during the screening period;
Proptosis ≥18 mm in the study eye;
A clinical diagnosis of chronic non-active TAO at screening was defined as CAS ≤2 in both eyes for at least 6 months prior to screening, or having all of the following characteristics: no progression of proptosis, no newly onset diplopia or diplopia progression induced by TED at least 6 months prior to screening, and no new inflammatory TAO symptoms.
Infertile female subjects or fertile female subjects with negative blood pregnancy test results during the screening period and agrees to take contraceptive measures from screening to 120 days after the last dose; male subjects should agree to use contraceptive measures from screening 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:
Decreased best-corrected visual acuity due to optic neuropathy (defined as a ≥ 2-line decrease in best-corrected visual acuity due to optic neuropathy within the past 180 days), newly emerging visual field defects or color vision impairment secondary to optic nerve damage;
Subjects with corneal ulcer;
Immediate orbital radiotherapy or orbital decompression as judged by investigators;
Orbital radiation therapy or surgical treatment for TAO, including orbital decompression, strabismus diorthosis and eyelid diorthosis, at any time before baseline, or planned to have the aforementioned treatments during the study;
Subjects with poorly controlled thyroid function, defined as FT3 or FT4 levels deviating from the normal reference ranges of the local study site laboratories by more than 50% at screening;

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Receiving Teprotumumab or IBI311 at any time before baseline;
Receiving anti-CD20 antibody or interleukin-6 receptor antibody treatment within 180 days prior to baseline;
Oral or intravenous administration of any other non-steroid immunosuppressant within 90 days prior to baseline

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: An Exploratory Study of the Efficacy and Safety of IBI311, a Modified Anti-IGF-1R Antibody, in Patients With Steroid-resistant, Thyroid Associated Ophthalmopathy

This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity.

Conditions: Thyroid Associated Ophthalmopathy
Being tested: Placebo, IBI311
Medical subject headings: Graves Ophthalmopathy

What participants receive

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

PlaceboDrug
Placebo group: 10 mg/kg of placebo on Day 1, followed by 20 mg/kg, q3W of placebo for the following 3 infusions.10 mg/kg of IBI311 at Week 12, followed by 20 mg/kg, q3W of IBI311 for the remaining 3 infusions.
IBI311Drug
IBI311 group: 10 mg/kg of IBI311 on Day 1, followed by 20 mg/kg, q3W of IBI311 for the remaining 7 infusions; .

Study groups in NCT06269393
Study group	Role	What they receive
Placebo	Placebo comparator	Participants with TAO will be randomized to receive 4 intravenous infusions of placebo with an interval of 3 weeks, followed by 4 intravenous infusions of IBI311 with an interval of 3 weeks. Receives: Drug: Placebo
IBI311	Active comparator	Participants with TAO will be randomized to receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Receives: Drug: IBI311

What is being measured

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

The proptosis responder rate (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) of the study eye.
Proptosis assessment: proptosis of the study eye as measured by Hertel exophthalmometer.
Measured: Week 12

Secondary outcomes (3)

Overall responder rate in proptosis of the study eye.
Proptosis assessment: proptosis of the study eye as measured by Hertel exophthalmometer.
Measured: Weeks 12 and 24
Percentage of subjects with a CAS value of 0 or 1
CAS Assessment Form
Measured: Weeks 12 and 24
Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia)
Gorman subjective diplopia score.
Measured: Weeks 12 and 24

Timeline

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

1 Jan 20243 Jul 2025

First posted21 Feb 2024
Study start1 Jan 2024
Primary completion3 Apr 2025
Study completion3 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Thyroid Associated OphthalmopathyStudies of the same condition, open and under way.
More trials run by Peking University People's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06269393
Sponsor's protocol ID: CIBI311Y101
Status last verified: Mar 2026
First submitted: 25 Jan 2024
Last updated: 24 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thyroid Associated Ophthalmopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of the Efficacy and Safety of IBI311, a Modified Anti-IGF-1R Antibody, in Patients With Steroid-resistant, Thyroid Associated Ophthalmopathy
ClinicalTrials.gov ID: NCT06269393
Acronym / sponsor ID: CIBI311Y101
Conditions: Thyroid Associated Ophthalmopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 3 Apr 2025 (actual)
Study completion: 3 Jul 2025 (actual)
First posted: 21 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants with TAO will be randomized to receive 4 intravenous infusions of placebo with an interval of 3 weeks, followed by 4 intravenous infusions of IBI311 with an interval of 3 weeks.
IBI311	Active comparator	Drug: IBI311Participants with TAO will be randomized to receive 8 intravenous infusions of IBI311 with an interval of 3 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Written informed consent.
Male or female subject between 18 and 80 years (inclusive) at Screening.
Steroid-resistant TAO, defined as poor response to steroid after completing a 3-month steroid pulse therapy (4.5g to 8.0g methylprednisolone) or 3-6 months of oral glucocorticoids treatment (i.e., CAS decreased by < 2 points, or proptosis decreased by < 2mm, or no improvement in diplopia), or relapse of TAO after steroid withdrawal (CAS increased by ≥2 points and CAS≥3 points [7-item scale] in either eye, or proptosis increased by ≥2 mm, or Gorman diplopia score increased by ≥1 point).
Moderate-to-severe active TAO or chronic TAO at screening:
Infertile female subjects or fertile female subjects with negative blood pregnancy test results during the screening period and agrees to take contraceptive measures from screening to 120 days after the last dose; male subjects should agree to use contraceptive measures from screening to 120 days after the last dose.

Key exclusion criteria (9 listed)

Subjects will be ineligible for study participation if they meet any of the following criteria:
Decreased best-corrected visual acuity due to optic neuropathy (defined as a ≥ 2-line decrease in best-corrected visual acuity due to optic neuropathy within the past 180 days), newly emerging visual field defects or color vision impairment secondary to optic nerve damage;
Subjects with corneal ulcer;
Immediate orbital radiotherapy or orbital decompression as judged by investigators;
Orbital radiation therapy or surgical treatment for TAO, including orbital decompression, strabismus diorthosis and eyelid diorthosis, at any time before baseline, or planned to have the aforementioned treatments during the study;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo group: 10 mg/kg of placebo on Day 1, followed by 20 mg/kg, q3W of placebo for the following 3 infusions.10 mg/kg of IBI311 at Week 12, followed by 20 mg/kg, q3W of IBI311 for the remaining 3 infusions.	Drug	Placebo
IBI311IBI311 group: 10 mg/kg of IBI311 on Day 1, followed by 20 mg/kg, q3W of IBI311 for the remaining 7 infusions; .	Drug	IBI311

Primary outcome

The proptosis responder rate (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) of the study eye.
Time frame: Week 12
Proptosis assessment: proptosis of the study eye as measured by Hertel exophthalmometer.

3 secondary outcomes

Overall responder rate in proptosis of the study eye.
Time frame: Weeks 12 and 24
Percentage of subjects with a CAS value of 0 or 1
Time frame: Weeks 12 and 24
Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia)
Time frame: Weeks 12 and 24

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.

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Active, not recruitingPhase 4
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Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wenhui Ren principal investigator

Peking University People's Hospital Research Office

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI311 in people with Thyroid Associated Ophthalmopathy, run by Peking University People's Hospital 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 12 inclusion and 9 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 24 Mar 2026. 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 phase mean?

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 (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) of the study eye. (time frame: Week 12). 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 NCT06269393.

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 24 Mar 2026.