A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease

Phase 2

• Conditions: Thyroid Ophthalmopathy
• Interventions: Drug: Placebo; Drug: HBM9161 680 mg qw by q2w from week 13; Drug: HBM9161 680 mg qw by q2w from week 7

• Registration Number: NCT05015127
• Lead Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.

Brief Summary

Primary Objective: To preliminarily evaluate the efficacy of the treatment regimen of HBM9161 680 mg administered subcutaneously weekly and sequentially every other week for 12 weeks in Chinese patients with active moderate to severe TED.

Detailed Description

This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, with the indication of TED. Subjects will be randomized to treatment group I, treatment group II, or placebo group. Subjects in treatment group 1 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 12 doses; Subjects in treatment group 2 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 6 doses, followed by HBM9161 680 mg subcutaneously once every two weeks (q2w) for 3 doses; Subjects in placebo group will receive placebo subcutaneously once weekly (qw) for 12 doses. After the 12-week dosing period, there will be a 5-week follow-up period.

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-20
• Study Start: 2021-09-22
• Status Verified: 2021-11
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-23
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Signed written informed consent form.
2. Male or female between the ages of 18 and 70 (including boundary values).
3. Active TED associated with a clinical diagnosis of Graves' disease or Hashimoto's thyroiditis with CAS ≥ 3 at the screening visit and baseline (both on a 7-item scale) in the eye with the most severe proptosis.
4. The active period of TED starts within 9 months prior to screening visit
5. Positive anti-TSHR antibody at screening visit.
6. Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.

Exclusion Criteria

1. Other uncontrolled concurrent diseases
2. Serious TED requiring surgery or radiotherapy
3. Suffer from autoimmune diseases or ophthalmic conditions other than TED that, in the opinion of the investigator, would impact the assessment of the study drug
4. No significant laboratory abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subcutaneous injection; Placebo
Placebo qw by HBM9161 680mg qw from week 12	Placebo	Placebo qw by HBM9161 680mg qw from week 12
HBM9161 680 mg qw by q2w from week 13	HBM9161 680 mg qw by q2w from week 13	Subcutaneous injection; HBM9161 680 mg qw from week 13
HBM9161 680 mg qw by q2w from week 7	HBM9161 680 mg qw by q2w from week 7	Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7

Primary Outcome Measures

Name	Time	Method
Proptosis responder rates of the treatment groups and placebo group at Week 12	At week 12	Proptosis responder rates of the treatment groups and placebo group at Week 12

Secondary Outcome Measures

Name	Time	Method
Diplopia response rate	At week 6, week 12, week 18 and week 24	Diplopia response rate
The change from Baseline in proptosis measurement in the study eye	At week 6, week 12, week 18 and week 24	The change from Baseline in proptosis measurement in the study eye
The changes in proptosis responder rate over time	From week 1 to week 24	The changes in proptosis responder rate over time
The percentage of subjects with a CAS value of 0 or 1 in the study eye	At week 6, week 12, week 18 and week 24	The percentage of subjects with a CAS value of 0 or 1 in the study eye
The change from baseline in quantitative measurement of orbital structures by MRI, including exophthalmos values, fatty tissue thickness of inner side in eye balls, thickness of extraocular muscles. All the above parameters will be measured in millimeter	At week 12, week 24	The change from baseline in quantitative measurement of orbital structures by MRI, including exophthalmos values, fatty tissue thickness of inner side in eye balls, thickness of extraocular muscles. All the above parameters will be measured in millimeter
Composite responder rate	At week 6, week 12, week 18 and week 24	Composite responder rate
The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score	At week 6, week 12, week 18 and week 24	The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China