Study of ZB001 in Chinese Patients With Thyroid Eye Disease

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody targeting human IGF-1R. The study is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics（PK）/pharmacodynamics (PD) profile of ZB001 in Chinese patients with Thyroid Eye Disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zenas BioPharma (USA), LLC

Criteria

Inclusion Criteria:

1. Adult male or female, 18 years of age or older

2. A clinical diagnosis of Graves'orbitopathy associated with TED with a CAS of ≥ 4 on the 7-item scale for the study eye

3. Moderate to severe (i.e., an appreciable impact on daily living) active TED: proptosis ≥ 18.6 mm, or progressive proptosis (≥ 3 mm higher than the patient's previous proptosis according to the investigator) and at least one of the following: lid retraction of ≥ 2 mm, moderate or severe soft tissue involvement (conjunctiva congestion or edema or periorbital congestion or edema), and/or periodic or constant diplopia

4. Documented evidence of ocular symptoms or signs associated with TED that began within 1 year before study screening

5. Euthyroid, or have only mild hyper- or hypothyroidism, defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels in the range of 0.5-1.5 times of the normal limits at Screening. Every effort must be made to correct any mild hypo- or hyperthyroidism promptly and maintain a euthyroid state for the entire duration of the study. Thyroidectomy is NOT an exclusion

6. Women of childbearing potential (including those having been postmenopausal for < 1 year, with amenorrhea for < 1 year or not surgically sterilized) must have a negative serum pregnancy test result at Screening; such patients must agree to practice effective contraception as described in the relevant protocol section (Section 9.2 Contraception and Pregnancy) for at least one full menstrual cycle before the first dose of study drug and continue to do so for 100 days after the last dose of study drug

7. Male patients must have been surgically sterilized for at least 6 weeks or agree to practice effective contraception as described in the relevant protocol section (Section 9.2 Contraception and Pregnancy) from prior to the first dose of study drug through 100 days after the last dose of study drug

Exclusion Criteria:

1. Decreased BCVA in the study eye, defined as ≥ 0.2 as measured using the standard logarithmic visual acuity chart, due to optic neuropathy, new visual field defect, or color defect secondary to optic nerve involvement within the previous 6 months

2. Corneal decompensation in the study eye unresponsive to medical management

3. A decrease in CAS of ≥ 2 points between screening assessment and Day -1

4. A decrease in proptosis of ≥ 2 mm in the study eye between screening assessment and Day -1

5. Had previous orbital irradiation or surgery in the study eye for TED

6. Known history of clinically significant ear pathology, ear surgery, or hearing impairment

7. Inflammatory bowel disease (e.g., biopsy-proven or clinical evidence of inflammatory bowel disease)

8. Cumulative glucocorticoid use equivalent to ≥ 1 g of methylprednisolone for the treatment of TED (previous treatment with a lower cumulative dose of glucocorticoid or eyedrop of glucocorticoid is permitted providing such treatment was discontinued ≥ 6 weeks before screening)

9. Used oral corticosteroids at any dose for conditions other than TED within 4 weeks before screening (topical use permitted)

10. Pregnancy or breastfeeding

11. Smoker (≥ 5 cigarettes per day) or former smoker (≥ 5 cigarettes per day) having quitted less than 6 months prior to enrollment in the study

12. Any vaccination planned during the study