Back to resultsA Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease
Primary Purpose
Thyroid Ophthalmopathy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HBM9161 680 mg qw by q2w from week 13
Placebo
HBM9161 680 mg qw by q2w from week 7
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Ophthalmopathy focused on measuring TED
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent form.
- Male or female between the ages of 18 and 70 (including boundary values).
- 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.
- The active period of TED starts within 9 months prior to screening visit
- Positive anti-TSHR antibody at screening visit.
- Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.
Exclusion Criteria:
- Other uncontrolled concurrent diseases
- Serious TED requiring surgery or radiotherapy
- 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
- No significant laboratory abnormalities
Sites / Locations
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
HBM9161 680 mg qw by q2w from week 13
HBM9161 680 mg qw by q2w from week 7
Placebo
Placebo qw by HBM9161 680mg qw from week 12
Arm Description
Subcutaneous injection; HBM9161 680 mg qw from week 13
Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7
Subcutaneous injection; Placebo
Placebo qw by HBM9161 680mg qw from week 12
Outcomes
Primary Outcome Measures
Proptosis responder rates of the treatment groups and placebo group at Week 12
Proptosis responder rates of the treatment groups and placebo group at Week 12
Secondary Outcome Measures
The percentage of subjects with a CAS value of 0 or 1 in the study eye
The percentage of subjects with a CAS value of 0 or 1 in the study eye
The change from Baseline in proptosis measurement in the study eye
The change from Baseline in proptosis measurement in the study eye
Composite responder rate
Composite responder rate
Diplopia response rate
Diplopia response rate
The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score
The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score
The changes in proptosis responder rate over time
The changes in proptosis responder rate over time
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
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
Full Information
NCT ID
NCT05015127
First Posted
August 3, 2021
Last Updated
February 22, 2022
Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05015127
Brief Title
A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Design Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Subcutaneous Injection in Chinese Patients With Active, Moderate to Severe Thyroid Eye Disease (TED)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Ophthalmopathy
Keywords
TED
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HBM9161 680 mg qw by q2w from week 13
Arm Type
Experimental
Arm Description
Subcutaneous injection; HBM9161 680 mg qw from week 13
Arm Title
HBM9161 680 mg qw by q2w from week 7
Arm Type
Experimental
Arm Description
Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Subcutaneous injection; Placebo
Arm Title
Placebo qw by HBM9161 680mg qw from week 12
Arm Type
Experimental
Arm Description
Placebo qw by HBM9161 680mg qw from week 12
Intervention Type
Drug
Intervention Name(s)
HBM9161 680 mg qw by q2w from week 13
Intervention Description
HBM9161 680 mg qw by q2w from week 13
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
HBM9161 680 mg qw by q2w from week 7
Intervention Description
HBM9161 680 mg qw by q2w from week 7
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo qw by HBM9161 680mg qw from week 12
Primary Outcome Measure Information:
Title
Proptosis responder rates of the treatment groups and placebo group at Week 12
Description
Proptosis responder rates of the treatment groups and placebo group at Week 12
Time Frame
At week 12
Secondary Outcome Measure Information:
Title
The percentage of subjects with a CAS value of 0 or 1 in the study eye
Description
The percentage of subjects with a CAS value of 0 or 1 in the study eye
Time Frame
At week 6, week 12, week 18 and week 24
Title
The change from Baseline in proptosis measurement in the study eye
Description
The change from Baseline in proptosis measurement in the study eye
Time Frame
At week 6, week 12, week 18 and week 24
Title
Composite responder rate
Description
Composite responder rate
Time Frame
At week 6, week 12, week 18 and week 24
Title
Diplopia response rate
Description
Diplopia response rate
Time Frame
At week 6, week 12, week 18 and week 24
Title
The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score
Description
The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score
Time Frame
At week 6, week 12, week 18 and week 24
Title
The changes in proptosis responder rate over time
Description
The changes in proptosis responder rate over time
Time Frame
From week 1 to week 24
Title
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
Description
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
Time Frame
At week 12, week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent form.
Male or female between the ages of 18 and 70 (including boundary values).
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.
The active period of TED starts within 9 months prior to screening visit
Positive anti-TSHR antibody at screening visit.
Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.
Exclusion Criteria:
Other uncontrolled concurrent diseases
Serious TED requiring surgery or radiotherapy
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
No significant laboratory abnormalities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huifang Zhou
Phone
+86 13661901886
Email
fangzzfang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Sun
Phone
+86 18516204866
Email
sophiasj@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huifang Zhou
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifang Zhou
Phone
+8613661901886
Email
fangzzfang@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease
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