Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

Genrix (Shanghai) Biopharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Biological: placebo; Biological: GR1802 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06216392

GR1802-004

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥4 at Baseline.
2. Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.

Exclusion criteria

1. Not enough washing-out period for previous therapy.
2. Concurrent disease/status which may potentially affect the efficacy/safety judgement.
3. Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.
4. Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.
5. Other

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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450 participants in 2 patient groups, including a placebo group

Experimental: GR1802

Experimental group

Description:

GR1802 injection 300mg every two weeks for 52-week treatment.

Treatment:

Biological: GR1802 injection

Placebo

Placebo Comparator group

Description:

Placebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks

Treatment:

Biological: placebo