Thyroid Eye DiseasePhase 2NCT06525506
A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
A Phase 2 study testing IBI311 (20 mg), IBI311 (3-20 mg) and IBI311 (10 mg) in people with Thyroid Eye Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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… 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 (20 mg), IBI311 (3-20 mg) and IBI311 (10 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2024to 22 Sep 2025
- Phase
- Phase 2
- 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 at screening.
- Weight between 50 kg and 100 kg.
- Moderate-to-severe active TED:
- CAS ≥ 3 in the study eye at screening and baseline;
- Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
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- ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;
- Inactive TED:
- According to subjects' chief complaint or medical record at screening, initial diagnosis of TED > 12 months but < 10 years prior to screening.
- CAS ≤ 2 in both eyes at screening and baseline and CAS ≤ 2 in both eyes for at least 6 months prior to screening or all of the following at least 6 months prior to screening: a. no progression in proptosis; b. no progression in diplopia; c. no new inflammatory TED symptoms.
- Exophthalmos ≥ 3 mm above normal.
- Exophthalmos ≥ 20 mm in the study eye at baseline.
- 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:
- Baseline CAS decreased by ≥ 2 points, or baseline proptosis decreased by ≥ 2 mm as compared with screening.
- Visual function impairment due to optic neuropathy, defined as ≥ 2 lines of vision loss, new visual field defect, or color vision impairment secondary to optic nerve involvement within the past 180 days;
- Corneal ulcers with no relief after treatment as determined by the investigator;
- TED patients who need immediate corticosteroid therapy, orbital radiotherapy, or orbital decompression;
- At any time prior to baseline or during the study period planned to receive orbital radiation therapy or TED surgery, including orbital decompression, strabismus surgery, and eyelid retraction correction;
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- Poorly controlled thyroid function, which was defined as free triiodothyronine (FT3) or free tetraiodothyronine (FT4) deviated more than 50% from the normal reference range of the local research center laboratory at screening.
- Either ear had a history of tinnitus or other hearing impairment; or abnormal pure tone audiometry (defined as mean bone conduction threshold [0.5, 1, 2, 4 kHz] ≥25 dB or any bone conduction threshold ≥ 40 dB);
- Poorly controlled diabetes at screening, defined as HbA1C ≥ 9.0% at screening, or any new medication for diabetes within 60 days prior to screening, or any dose adjustment for diabetes drugs > 10%);
- Systemic use of glucocorticoids ≤ 30 days prior to screening;
- Periorbital use of glucocorticoids ≤ 90 days prior to screening;
- Systemic use of immunosuppressants ≤ 90 days prior to screening;
- Use glucocorticoid eye drops or immunosuppressive eye drops ≤ 30 days prior to screening
- 12. Use IBI311 or TEPEZZA at any time prior to screening; 13 Use CD20 antibody ≤ 1 year prior to screening, or IL-6R antibody ≤ 180 days prior to screening; 14. Subjects had participated in other interventional clinical trials ≤ 90 days prior to screening, or attempting to participate in other clinical trials during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Masked Phase II Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
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
- Being tested
- IBI311 (20 mg), IBI311 (3-20 mg), IBI311 (10 mg), IBI311 (3-10mg/kg)
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI311 (20 mg)Biological
Arm 4: 10 mg/kg IBI311 on Day 1, followed by 20 mg/kg IBI311 from week 3 to week 21, Q3W.
IBI311 (3-20 mg)Biological
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.
IBI311 (10 mg)Biological
Arm 3: 10 mg/kg IBI311 from day 1 to week 21, Q3W.
IBI311 (3-10mg/kg)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2: IBI311 (3-20 mg) | Active comparator | Arm 2: IBI311 (3-20 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Dose conversion was performed at week 12. Receives: Biological: IBI311 (3-20 mg) |
| Arm 4: IBI311 (20 mg) | Active comparator | Arm 4: IBI311 (20 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Receives: Biological: IBI311 (20 mg) |
| Arm 3: IBI311 (10 mg) | Active comparator | Arm 3: IBI311 (10 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Receives: Biological: IBI311 (10 mg) |
| Arm 1: IBI311 (3-10 mg) | Active comparator | Arm 1: IBI311 (3-10 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Dose conversion was performed at week 12. Receives: Biological: IBI311 (3-10mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline in proptosis in the study eye.
Proptosis assessment: protrusion of the eye from the orbital rim as measured by Hertel exophthalmometer.
Measured: Week 12
Safety and Tolerability
Incidence, severity, and association with the study drug of ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE).
Measured: After receiving IBI311 treatment for 48 weeks
Secondary outcomes (11)
The proptosis responder rate in the study eye
Defined as percentage of subjects with a ≥ 2 mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye.
Measured: Week 12, 24 and 48
Mean change from Baseline in proptosis in the study eye.
Proptosis assessment: protrusion of the eye from the orbital rim as measured by Hertel exophthalmometer.
Measured: Week 24 and 48
The overall responder rate in the study eye.
Defined as participants with a reduction in clinical activity score (CAS) 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: Week 12, 24 and 48
Percentage of subjects with a CAS 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: Week 12, 24 and 48
Mean change from Baseline in CAS in the study eye.
Measured: Week 12, 24 and 48
Positive responder rate to IBI311 treatment in the study eye.
Defined as:
- ≥2 mm reduction of lid aperture;
- ≥1 point reduction in five-item CAS (excluding subjective, patient-reported spontaneous or gaze-evoked pain),
- ≥2 mm reduction in exophthalmos,
- ≥8° increase of eye muscle duction; Improvement in ≥2 features in the study eye without deterioration in the non-study eye
Measured: Week 12, 24 and 48
The impact of IBI311 on the quality of life.
Changes in Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire score
Measured: Week 12, 24 and 48
The diplopia responder rate
Defined as subjects with a ≥ 1-point improvement in Gorman diplopia score.
Measured: Week 12, 24 and 48
The relapse rate after IBI311 treatment
Defined as proptosis increased by ≥2 mm from baseline and/or CAS increased by ≥2 points from baseline with total CAS score ≥3 in either eye.
Measured: Week 28, 36 and 48
Systemic Pharmacokinetics profile of IBI311
Descriptive statistics will be performed for concentration data, and the corresponding Pharmacokinetics parameters will be estimated if sufficient data are available.
Measured: From Day 1 to week 24
Change from Baseline in MRI in the study eye.
Changes in exophthalmia from baseline on MRI at week 12, 24, and 48; Changes in the volume and maximum thickness of extraocular muscle, orbital fat and lacrimal gland on MRI from baseline at week 12, 24 and 48; Changes in MRI signal of intraorbital tissue from baseline at week 12, 24 and 48.
Measured: Week 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start4 Sep 2024
- Primary completion9 Jan 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525506
- Sponsor's protocol ID
- CIBI311A202
- Status last verified
- Oct 2024
- First submitted
- 24 Jul 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked Phase II Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06525506
- Acronym / sponsor ID
- CIBI311A202
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 29 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 2: IBI311 (3-20 mg) | Active comparator | Biological: IBI311 (3-20 mg)Arm 2: IBI311 (3-20 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Dose conversion was performed at week 12. |
| Arm 4: IBI311 (20 mg) | Active comparator | Biological: IBI311 (20 mg)Arm 4: IBI311 (20 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. |
| Arm 3: IBI311 (10 mg) | Active comparator | Biological: IBI311 (10 mg)Arm 3: IBI311 (10 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. |
| Arm 1: IBI311 (3-10 mg) | Active comparator | Biological: IBI311 (3-10mg/kg)Arm 1: IBI311 (3-10 mg). Participants will receive 8 intravenous infusions of IBI311 with an interval of 3 weeks. Dose conversion was performed at week 12. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent.
- Male or female subject between the ages of 18 and 80 years at screening.
- Weight between 50 kg and 100 kg.
- Moderate-to-severe active TED:
- Exophthalmos ≥ 20 mm in the study eye at baseline.
Key exclusion criteria (14 listed)
- Subjects will be ineligible for study participation if they meet any of the following criteria:
- Baseline CAS decreased by ≥ 2 points, or baseline proptosis decreased by ≥ 2 mm as compared with screening.
- Visual function impairment due to optic neuropathy, defined as ≥ 2 lines of vision loss, new visual field defect, or color vision impairment secondary to optic nerve involvement within the past 180 days;
- Corneal ulcers with no relief after treatment as determined by the investigator;
- TED patients who need immediate corticosteroid therapy, orbital radiotherapy, or orbital decompression;
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 |
|---|---|---|
| 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 | Arm 4: IBI311 (20 mg) |
| 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 | Arm 2: IBI311 (3-20 mg) |
| IBI311 (10 mg)Arm 3: 10 mg/kg IBI311 from day 1 to week 21, Q3W. | Biological | Arm 3: IBI311 (10 mg) |
| 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. | Biological | Arm 1: IBI311 (3-10 mg) |
Primary outcome
Mean change from Baseline in proptosis in the study eye.
Time frame: Week 12
Proptosis assessment: protrusion of the eye from the orbital rim as measured by Hertel exophthalmometer.
Safety and Tolerability
Time frame: After receiving IBI311 treatment for 48 weeks
Incidence, severity, and association with the study drug of ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE).
11 secondary outcomes
The proptosis responder rate in the study eye
Time frame: Week 12, 24 and 48
Mean change from Baseline in proptosis in the study eye.
Time frame: Week 24 and 48
The overall responder rate in the study eye.
Time frame: Week 12, 24 and 48
Percentage of subjects with a CAS of 0 or 1 in the study eye.
Time frame: Week 12, 24 and 48
Mean change from Baseline in CAS in the study eye.
Time frame: Week 12, 24 and 48
Positive responder rate to IBI311 treatment in the study eye.
Time frame: Week 12, 24 and 48
The impact of IBI311 on the quality of life.
Time frame: Week 12, 24 and 48
The diplopia responder rate
Time frame: Week 12, 24 and 48
The relapse rate after IBI311 treatment
Time frame: Week 28, 36 and 48
Systemic Pharmacokinetics profile of IBI311
Time frame: From Day 1 to week 24
Change from Baseline in MRI in the study eye.
Time frame: Week 12, 24 and 48
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 3 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI311 (20 mg), IBI311 (3-20 mg) and IBI311 (10 mg) 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 13 inclusion and 14 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 3 Oct 2025. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change from Baseline in proptosis in the study eye. (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.