Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05180526
Other study ID # BAT-1406-006-CR
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 27, 2021
Est. completion date May 30, 2024

Study information

Verified date April 2023
Source Bio-Thera Solutions
Contact Zhihao Li, Master
Phone +86-1300 5111 931
Email zhli2@bio-thera.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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) : the inclusion and exclusion criteria were evaluated, and those meeting the criteria could enter the treatment period. Treatment period (1-22 weeks) : Eligible subjects with non-infectious uveitis were given an initial subcutaneous injection of 80 mg at week 1, followed by a subcutaneous injection of 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (a total of 12 doses). Follow-up period: Follow-up for safety and/or efficacy is recommended at 6, 12, 24, and 32 weeks after initiation of the study drug. A final visit will be made at 32 weeks. During the study, if the condition of the subjects or their symptoms and signs become worse, the investigator can adjust the use of drugs for uveitis other than study drugs according to the actual situation of the subjects. At the same time, plasma concentration will be determined before D1, D78 (week 12), and D162 (week 24); Immunogenicity analysis was performed before D1 administration, before D78 (week 12), before D162 (week 24) and before D218 (week 32)


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 30, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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; Exclusion Criteria: - 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; - One-eyed patients deemed unsuitable for inclusion by the investigator; - 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; - Had been treated with vitreous Retisert (glucocorticoid implant) or had complications with the implant during the 36 months prior to baseline; Removal of Retisert within 90 days prior to baseline or complications of removal. - Having any of the following general conditions: - Subjects meet any of the following criteria associated with latent or active tuberculosis (TB) infection: . A history of active TB = 3 years before screening (but can also be included if it is > 3 years and documented completion of adequate treatment); B. Signs or symptoms suggestive of active TB at the time of screening in the history and/or physical examination; C. Recent close contact with someone with active TB; D. If a TB infection T-cell test is positive at the time of screening, subjects will be excluded from the study if their first TB infection T-cell test is inconclusive. For suitable standards has been completed before screening latent TB treatment and no other risk factors, imaging findings, or support the latent or signs of active TB specific subjects, for positive or uncertain results may be the exception handling, researchers with the qualified physician judgment, tuberculosis (including extrapulmonary) risk, decision and discuss with bidders; - Positive hepatitis C antibody during screening; Or HIV antibody positive; Or treponema pallidum antibody positive; - Symptoms of severe, progressive or uncontrollable kidney, liver, blood, gastrointestinal, lung, cardiovascular, neurological or brain disease. The investigator felt that participating in the study placed patients at unacceptable risk. - Patients with malignant tumors. - Patients with moderate to severe heart failure (New York Heart Society Grades 3-4). - History of severe allergy or anaphylactoid reaction to monoclonal antibodies. - Prior treatment with anti-TUMOR necrosis factor TNF or other biological agents with potential therapeutic effect for uveitis (excluding intravitreal anti-VEGF drugs). - During the 30 days prior to baseline, the combined dose of other immunosuppressant therapy increased or did not meet any of the following conditions: methotrexate MTX=25mg/ week; Cyclosporine =4 mg/kg/ day; Mycophenolate (or equivalent dose of mycophenolate) =2g/ day; Azathioprine =175 mg/ day; Tacrolimus oral =8 mg/ day. - Received clinical trial drug intervention within 3 months prior to screening. - Received any live vaccine within 3 months prior to receiving the first dose of the study drug, or planned to receive live vaccine during the study period. - There are contraindications to dilatation drugs. - Patients judged unsuitable for inclusion by other investigators

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
QLETLI
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).

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing
China The Second Xiangya Hospital of Central South University Changsha
China The First Affiliated Hospital of Chongqing Medical University Chongqing
China The second hospital of Jilin University Jilin
China Tianjin Medical University Eye Hospital Tianjin
China Renmin Hospital of Wuhan University Wuhan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Bio-Thera Solutions

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 treatment failure rate Treatment failure rate at each visit point from first administration to 24 weeks.Treatment failure was defined as meeting at least one of the following conditions in at least one eye: newly active inflammatory choroiditis or retinal vasculopathy [from baseline]; The anterior chamber cell grading or vitreous opacity grading did not reach ?0.5+ during the 6 weeks visit, or the optimal condition did not improve in all visits after 6 weeks. Best corrected visual acuity decreased by ?15 letters compared to best condition 6/12/24week
Secondary Changes in ocular inflammation changes in anterior chamber cell grade 6/12/24week
Secondary Changes in ocular inflammation changes in vitreous turbidity 6/12/24week
Secondary Changes in ocular inflammation changes in macular edema 6/12/24week
Secondary Changes in ocular inflammation changes in central retinal thickness 6/12/24week
Secondary Changes in visual acuity Changes in visual acuity 6/12/24week
Secondary Changes in visual function scale VFQ-25 Changes in visual function scale VFQ-25 6/12/24week
See also
  Status Clinical Trial Phase
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Active, not recruiting NCT04704609 - Imaging Quantification of Inflammation (IQI)
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Withdrawn NCT01280669 - Intravitreal Sirolimus as Therapeutic Approach to Uveitis Phase 2
Terminated NCT02907814 - Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography N/A
Active, not recruiting NCT02252328 - Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients Phase 2/Phase 3
Completed NCT04183387 - Simvastatin in Uveitis Phase 2
Completed NCT01983488 - Clinical Outcome in Uveitis
Withdrawn NCT00499551 - A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis Phase 1/Phase 2
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Completed NCT00132691 - Multicenter Uveitis Steroid Treatment (MUST) Trial Phase 4
Terminated NCT00114062 - Study to Treat Uveitis Associated Macular Edema Phase 2
Completed NCT00001867 - Effect of Pregnancy on Uveitis N/A
Completed NCT00379275 - Eye and Immunogenetic Features of Sarcoidosis N/A
Active, not recruiting NCT03828019 - Adalimumab vs. Conventional Immunosuppression for Uveitis Trial Phase 3
Terminated NCT01939691 - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial Phase 4
Active, not recruiting NCT03889860 - Objective Choroidal Thickness Measurements in Uveitis
Completed NCT00070759 - Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis Phase 2
Recruiting NCT05486468 - The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment Phase 3
Active, not recruiting NCT05385757 - UNICORNS: Uveitis in Childhood Prospective National Cohort Study