Atopic Dermatitis
Conditions
Keywords
TSLP
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 patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks.
Interventions
BIOLOGICALGR2002 injection
TSLP monoclonal antibody
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. 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; 2. Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD; 3. Voluntary informed consent. Main
Exclusion criteria
1. Current malignancy or history of malignancy; 2. History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation; 3. Subjects may have active Mycobacterium tuberculosis infection; 4. Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit; 5. History of known or suspected immunosuppression; 6. Presence of skin comorbidities that may interfere with evaluation; 7. Suspected or confirmed allergy to the test drug (including excipients, similar drugs); 8. History of alcohol or drug abuse within 3 months prior to screening； 9. Pregnant or lactating women who need to breastfeed； 10. Major surgery planned during the trial； 11. The elution cycle of the drug of interest is not met at the baseline； 12. Subjects of childbearing potential and partners refusing to use highly effective contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Within 20 weeks | Incidence of AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGA Response | Within 20 weeks | Proportion of subjects with an IGA score of 0-1 and a decrease of ≥2 points from baseline |
| EASI 50/75/90 Response | Within 20 weeks | Proportion of subjects with ≥50%, ≥75%, and ≥90% improvement in EASI score |
| Pharmacokinetics parameters | Within 20 weeks | concentration of GR2002 |
| Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3 | Within 20 weeks | Proportion of subjects with ≥4/3-point decrease in PP-NRS from baseline |
| immunogenicity | Within 20 weeks | Detection of anti-drug antibody(ADA) |
| Percentage change in BSA score | Within 20 weeks | Percentage change from baseline in BSA involvement in atopic dermatitis lesions |
Countries
China
Contacts
Primary ContactJianzhong Zhang, PHD
Backup ContactXuewenjun Zhang, MD
Outcome results
None listed