NCT06175143Not yet recruitingPhase 1
A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GR2002 Injection in Patients With Moderate to Severe Atopic Dermatitis
Genrix (Shanghai) Biopharmaceutical Co., Ltd.1 site in 1 country40 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse events (AEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
GR2002 injection 2
Experimental
GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency
Intervention: GR2002 injection (Biological)
GR2002 injection 3
Experimental
GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency
Intervention: GR2002 injection (Biological)
GR2002 injection 1
Experimental
GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency
Intervention: GR2002 injection (Biological)
GR2002 injection 4
Experimental
GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency
Intervention: GR2002 injection (Biological)
Outcomes
Primary Outcomes
Adverse events (AEs)
Time Frame: Within 20 weeks
Incidence of AEs.
Secondary Outcomes
- IGA Response(Within 20 weeks)
- EASI 50/75/90 Response(Within 20 weeks)
- immunogenicity(Within 20 weeks)
- Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3(Within 20 weeks)
- Pharmacokinetics parameters(Within 20 weeks)
- Percentage change in BSA score(Within 20 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 1
A Study to Evaluate the Safety and Effect of STC314 Injection Continuous Infusion in Subjects With Acute Respiratory Distress SyndromeAcute Respiratory Distress SyndromeNCT05000671Grand Medical Pty Ltd.16
Completed
Phase 1
SG301-SC Injection Safety Study in Subjects With Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)NCT06144710Hangzhou Sumgen Biotech Co., Ltd.48
Completed
Phase 1
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSVRSV InfectionNCT05779995Hangzhou Sciwind Biosciences Co., Ltd.61
Completed
Phase 1
Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With AsthmaAsthmaNCT04576325TFF Pharmaceuticals, Inc.17
Completed
Phase 2
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentAlcoholic HepatitisNCT04563026Durect307