Assessment of Safety , Clinical Efficacy with QLETLI in Non-infectious Uveitis (UV)

NCT05180526 | Active Not Recruiting Phase 4

• 1 other identifier: BAT-1406-006-CR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2\~0 weeks) ,Treatment period (1-22 weeks), Follow-up period, At the same time, plasma concentration will be determined

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• Duration of treatment failure

  Duration of treatment failure at 6 weeks of treatment or between 6 and 24 weeks of treatment (treatment failure is defined as meeting at least one of the following conditions in at least one eye:

  6\12\24week

Secondary Outcomes (7)

• treatment failure rate

  6/12/24week

• Changes in ocular inflammation

  6/12/24week

• Changes in ocular inflammation

  6/12/24week

• Changes in ocular inflammation

  6/12/24week

• Changes in ocular inflammation

  6/12/24week

Study Arms (1)

Experimental

EXPERIMENTAL

80 mg was given subcutaneously at week 1, followed by 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (12 doses).

Drug: QLETLI

Interventions

QLETLI DRUG

80 mg was given subcutaneously at week 1, followed by 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (12 doses).

Experimental

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily participated in the study and signed informed consent
• Aged between 18 and 70 (including threshold), male or female;
• Diagnosis of non-infectious intermediate, posterior, or total uveitis in at least one eye;
• Received maintenance therapy (oral prednisone 10-60mg/day or equivalent glucocorticoid for ≧2 weeks before screening, and no dose adjustment from screening to baseline;
• At baseline, at least one eye was diagnosed with active uveitis, presenting as meeting at least one of the following criteria: active inflammatory chorioretinal and/or inflammatory retinal vasculopathy; Cell grade of anterior chamber ≧2+; Degree of vitreous turbid ≧2+;
• Negative serum pregnancy test results of women of childbearing age during screening visits;

You may not qualify if:

• Patients with the following eye conditions:
• Patients with simple anterior uveitis;
• Uveitis with macular edema as the only manifestation;
• is confirmed or suspected infectious uveitis (including but not limited to the following causes of infectious uveitis, tuberculosis, cytomegalovirus, lyme disease, toxoplasmosis, human, T, Whipple's disease virus type 1 infection, herpes zoster virus and herpes simplex virus) or disguise syndrome (for example: eye trauma, lymphoma, malignant tumor, or surgery, etc.);
• Uncontrolled glaucoma, defined as intraocular pressure higher than 25 mmHg after drug treatment, or optic nerve damage;
• Best corrected visual acuity of less than 20 letters in at least one eye at baseline;
• With other fundus diseases (such as fertile or serious non fertile diabetic retinopathy or diabetic retinopathy with clinical significance of macular edema, retinal vein occlusion, macular degeneration, age, sex, blood vessel patterns change, the pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);
• Demyelinating disease (including myelitis and optic neuritis) or a history of neurology suggesting symptoms of demyelinating disease (including but not limited to optic neuritis);
• Refractive media opacity or pupil failure that significantly interferes with visual acuity detection, anterior segment and fundus assessment;
• Peribulbar, intravitreal or subocular corticosteroid injections were given within 30 days prior to screening;
• Posterior capsulotomy was performed within 30 days prior to screening;
• Cataract surgery is expected within 90 days prior to screening or during the study period;
• An intravitreal injection of anti-VEGF therapy (e.g., raizumab, apecivir, or Combocept) within 90 days prior to baseline;
• Ozurdex implants (dexamethasone implants) were performed within 6 months prior to baseline;
• Treatment with intravitreal injection of methotrexate within 90 days prior to baseline;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (7)

Peking Union Medical College Hospital

Beijing, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

The second hospital of Jilin University

Jilin, China

Location

Tianjin Medical University Eye Hospital

Tianjin, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Peizeng Yang, M.D

  1 Youyi Road, Yuzhong District, Chongqing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 6, 2022
• Study Start: December 27, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)