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

NCT05015127 | Unknown Phase 2

• 1 other identifier: 9161.5
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Ophthalmopathy

Keywords

TED

Outcome Measures

Primary Outcomes (1)

• 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

  At week 12

Secondary Outcomes (7)

• 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 change from Baseline in proptosis measurement in the study eye

  At week 6, week 12, week 18 and week 24

• Composite responder rate

  At week 6, week 12, week 18 and week 24

• Diplopia response rate

  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

  At week 6, week 12, week 18 and week 24

Study Arms (4)

HBM9161 680 mg qw by q2w from week 13

EXPERIMENTAL

Subcutaneous injection; HBM9161 680 mg qw from week 13

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

Drug: HBM9161 680 mg qw by q2w from week 7

Placebo

EXPERIMENTAL

Subcutaneous injection; Placebo

Drug: Placebo

Placebo qw by HBM9161 680mg qw from week 12

EXPERIMENTAL

Placebo qw by HBM9161 680mg qw from week 12

Drug: Placebo

Interventions

HBM9161 680 mg qw by q2w from week 13 DRUG

HBM9161 680 mg qw by q2w from week 13

HBM9161 680 mg qw by q2w from week 13

Placebo DRUG

Placebo

Placebo

HBM9161 680 mg qw by q2w from week 7 DRUG

HBM9161 680 mg qw by q2w from week 7

HBM9161 680 mg qw by q2w from week 7

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

HBM9161

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Huifang Zhou

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huifang Zhou

CONTACT

+86 13661901886; fangzzfang@163.com

Jing Sun

CONTACT

+86 18516204866; sophiasj@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 20, 2021
• Study Start: September 22, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 23, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)