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Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis

NCT05544591 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-02-01

No results posted yet for this study

Summary

The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

611 Q2W

subcutaneous injection, 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 2 to Week 14, 7 cycles)

DRUG

611 Q4W

subcutaneous injection, 600mg (loading dose, Day1) + 300mg Q4W (maintenance dose, on week 4, 8, 12) + placebo Q4W (on week 2, 6, 10, 14)

DRUG

Matching placebo

subcutaneous injection, Q2W, from Week 2 to Week 14, 7 cycles

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2023-07-10
Completion
2023-09-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05544591 on ClinicalTrials.gov