A Study of IBI311 in Subjects With Active Thyroid Eye Disease

Browse trials for

• Eye Diseases 740
• Graves Ophthalmopathy 191
• Thyroid Diseases 967

Eye Diseases

740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.

This study's enrollment of 115 is above the median of 68 across 547 interventional studies indexed under Eye Diseases.

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Eligibility criteria

Study arms

• Placebo comparator
  Placebo

  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

• Active comparator
  IBI311

  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

• BiologicalIBI311

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

• Biologicalplacebo

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

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

   Time frame: Week 12 for phase II, Week 24 for phase III

Secondary outcomes

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.)

   Time frame: 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.

   Time frame: Week12 and Week24 for phase II, Week 24 for phase III

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

   Time frame: 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

   Time frame: 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

   Time frame: Week 24 for phase II

6. The diplopia responder rate of the study eye.

   Time frame: Week12 and Week24 for phase II, Week 24 for phase III

Individual participant data

Plan to share: No