NCT06175143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 18, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

November 23, 2023

Last Update Submit

December 8, 2023

Conditions

Atopic Dermatitis

Keywords

TSLP

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Incidence of AEs.

    Within 20 weeks

Secondary Outcomes (6)

  • Pharmacokinetics parameters

    Within 20 weeks

  • IGA Response

    Within 20 weeks

  • EASI 50/75/90 Response

    Within 20 weeks

  • Percentage change in BSA score

    Within 20 weeks

  • Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3

    Within 20 weeks

  • +1 more secondary outcomes

Study Arms (4)

GR2002 injection 1

EXPERIMENTAL

GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency

Biological: GR2002 injection

GR2002 injection 2

EXPERIMENTAL

GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency

Biological: GR2002 injection

GR2002 injection 3

EXPERIMENTAL

GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency

Biological: GR2002 injection

GR2002 injection 4

EXPERIMENTAL

GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency

Biological: GR2002 injection

Interventions

GR2002 injectionBIOLOGICAL

TSLP monoclonal antibody

GR2002 injection 1GR2002 injection 2GR2002 injection 3GR2002 injection 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jianzhong Zhang, PHD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • Cheng Zhou, PHD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianzhong Zhang, PHD

CONTACT

010-88325472rmzjz@126.com

Xuewenjun Zhang, MD

CONTACT

021-50805989-8324zhangxuewenjun@genrixbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 18, 2023

Study Start

December 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

December 18, 2023

Record last verified: 2023-11

Locations

CN(1)