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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyroid Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HBM9161 680 mg qw by q2w from week 13

Subcutaneous injection; HBM9161 680 mg qw from week 13

Group Type EXPERIMENTAL

HBM9161 680 mg qw by q2w from week 13

Intervention Type DRUG

HBM9161 680 mg qw by q2w from week 13

HBM9161 680 mg qw by q2w from week 7

Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7

Group Type EXPERIMENTAL

HBM9161 680 mg qw by q2w from week 7

Intervention Type DRUG

HBM9161 680 mg qw by q2w from week 7

Placebo

Subcutaneous injection; Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo

Placebo qw by HBM9161 680mg qw from week 12

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo qw by HBM9161 680mg qw from week 12

Interventions

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HBM9161 680 mg qw by q2w from week 13

Intervention Type DRUG

Placebo

Intervention Type DRUG

HBM9161 680 mg qw by q2w from week 7

Intervention Type DRUG

Placebo

Placebo qw by HBM9161 680mg qw from week 12

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No