Thyroid OphthalmopathyPhase 2/3NCT05015127
A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease
A Phase 2/3 study testing HBM9161 680 mg qw by q2w from week 13 and HBM9161 680 mg qw by q2w from week 7 in people with Thyroid Ophthalmopathy, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Ophthalmopathy
- What is being tested?
- HBM9161 680 mg qw by q2w from week 13 and HBM9161 680 mg qw by q2w from week 7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2021to Dec 2022
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Huifang Zhou, +8613661901886, fangzzfang@163.com
About this study
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)
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.
Read the 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.
- Conditions
- Thyroid Ophthalmopathy
- Being tested
- HBM9161 680 mg qw by q2w from week 13, Placebo, HBM9161 680 mg qw by q2w from week 7
- Keywords
- TED
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM9161 680 mg qw by q2w from week 13Drug
HBM9161 680 mg qw by q2w from week 13
PlaceboDrug
Placebo
HBM9161 680 mg qw by q2w from week 7Drug
HBM9161 680 mg qw by q2w from week 7
PlaceboDrug
Placebo qw by HBM9161 680mg qw from week 12
| Study group | Role | What they receive |
|---|---|---|
| HBM9161 680 mg qw by q2w from week 13 | Experimental | Subcutaneous injection; HBM9161 680 mg qw from week 13 Receives: Drug: HBM9161 680 mg qw by q2w from week 13 |
| HBM9161 680 mg qw by q2w from week 7 | Experimental | Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7 Receives: Drug: HBM9161 680 mg qw by q2w from week 7 |
| Placebo | Experimental | Subcutaneous injection; Placebo Receives: Drug: Placebo |
| Placebo qw by HBM9161 680mg qw from week 12 | Experimental | Placebo qw by HBM9161 680mg qw from week 12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At week 12
Secondary outcomes (7)
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
Measured: At week 6, week 12, week 18 and week 24
The change from Baseline in proptosis measurement in the study eye
The change from Baseline in proptosis measurement in the study eye
Measured: At week 6, week 12, week 18 and week 24
Composite responder rate
Composite responder rate
Measured: At week 6, week 12, week 18 and week 24
Diplopia response rate
Diplopia response rate
Measured: 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
The change from baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire visual function score and psychosocial function score
Measured: At week 6, week 12, week 18 and week 24
The changes in proptosis responder rate over time
The changes in proptosis responder rate over time
Measured: From week 1 to 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
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
Measured: At week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start22 Sep 2021
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid OphthalmopathyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huifang Zhou, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015127
- Sponsor's protocol ID
- 9161.5
- Status last verified
- Nov 2021
- First submitted
- 3 Aug 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05015127
- Acronym / sponsor ID
- 9161.5
- Conditions
- Thyroid Ophthalmopathy
- Keywords
- TED
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Aug 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HBM9161 680 mg qw by q2w from week 13 | Experimental | Drug: HBM9161 680 mg qw by q2w from week 13Subcutaneous injection; HBM9161 680 mg qw from week 13 |
| HBM9161 680 mg qw by q2w from week 7 | Experimental | Drug: HBM9161 680 mg qw by q2w from week 7Subcutaneous injection; HBM9161 680 mg qw by q2w from week 7 |
| Placebo | Experimental | Drug: PlaceboSubcutaneous injection; Placebo |
| Placebo qw by HBM9161 680mg qw from week 12 | Experimental | Drug: PlaceboPlacebo qw by HBM9161 680mg qw from week 12 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| HBM9161 680 mg qw by q2w from week 13HBM9161 680 mg qw by q2w from week 13 | Drug | HBM9161 680 mg qw by q2w from week 13 |
| PlaceboPlacebo | Drug | Placebo |
| HBM9161 680 mg qw by q2w from week 7HBM9161 680 mg qw by q2w from week 7 | Drug | HBM9161 680 mg qw by q2w from week 7 |
| PlaceboPlacebo qw by HBM9161 680mg qw from week 12 | Drug | Placebo qw by HBM9161 680mg qw from week 12 |
Primary outcome
Proptosis responder rates of the treatment groups and placebo group at Week 12
Time frame: At week 12
Proptosis responder rates of the treatment groups and placebo group at Week 12
7 secondary outcomes
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
The change from Baseline in proptosis measurement in the study eye
Time frame: At week 6, week 12, week 18 and week 24
Composite responder rate
Time frame: At week 6, week 12, week 18 and week 24
Diplopia response rate
Time frame: 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
Time frame: At week 6, week 12, week 18 and week 24
The changes in proptosis responder rate over time
Time frame: From week 1 to 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
Time frame: At week 12, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Huifang Zhou principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HBM9161 680 mg qw by q2w from week 13 and HBM9161 680 mg qw by q2w from week 7 in people with Thyroid Ophthalmopathy, run by Harbour BioMed (Guangzhou) 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huifang Zhou (+86 13661901886, fangzzfang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proptosis responder rates of the treatment groups and placebo group at Week 12 (time frame: At week 12). 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 23 Feb 2022.