Status:
UNKNOWN
A Study to Evaluate the Safety and Efficacy of GR2002 Injection in Patients With Atopic Dermatitis.
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in pati...
Eligibility Criteria
Inclusion
- Main
- Patients need to meet Williams diagnostic criteria, have had AD for at least 1 year, and:EASI ≥16, IGA score ≥3, and AD involvement of ≥10% of BSA;
- Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD;
- Voluntary informed consent.
- Main
Exclusion
- Current malignancy or history of malignancy;
- History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
- Subjects may have active Mycobacterium tuberculosis infection;
- Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit;
- History of known or suspected immunosuppression;
- Presence of skin comorbidities that may interfere with evaluation;
- Suspected or confirmed allergy to the test drug (including excipients, similar drugs);
- History of alcohol or drug abuse within 3 months prior to screening；
- Pregnant or lactating women who need to breastfeed；
- Major surgery planned during the trial；
- The elution cycle of the drug of interest is not met at the baseline；
- Subjects of childbearing potential and partners refusing to use highly effective contraception.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06175143
Start Date
December 1 2023
End Date
October 1 2024
Last Update
December 18 2023
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044