Health TrialsbyHealthPanel

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis

ConditionModerate-to-severe Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.

At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.

Have atopic dermatitis at screening.

Disqualifiers

Hypersensitivity to the study drug or any ingredient in the study drug.

Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).

Has malignancy or has a history of malignancy.

Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1905 Injection

    Drug

    SHR-1905 injection.

  • SHR-1905 Injection Blank Preparation

    Drug

    SHR-1905 injection blank preparation.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: SHR-1905 Injection Group - Dose 1Experimental treatment 1 intervention
Group B: SHR-1905 Injection Placebo GroupPlacebo comparator 1 intervention
Group C: SHR-1905 Injection Group - Dose 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of subjects whose Eczema Area and Severity Index (EASI) score decreased ≥ 75% compared to the baseline.

Eczema Area and Severity Index (EASI) score using the Eczema Area and Severity Index scale.

Time frame
Week 16.

Secondary outcomes

1

The proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale) and a decrease of ≥2 points from the baseline.

Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.

Time frame
At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
2

The proportion of subjects whose Investigator's Global Assessment (IGA) score decreased ≥ 2 points compared to the baseline.

Investigator's Global Assessment (IGA) score using the Investigator Global Assessment (IGA) scale.

Time frame
At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
3

The change value of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.

The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.

Time frame
At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.
4

The percentage of change in the Itch Numeric Rating Scale (Itch-NRS) score from the baseline.

The Itch Numeric Rating Scale (Itch-NRS) score using the the Worst Itch Numeric Rating Scale.

Time frame
At Day14、Day28、Day56、Day84、Day112、Day140、Day168、Day210、Day252.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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