To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    240
  • sponsor
    Sun Pharmaceutical Industries Limited
Updated on 7 October 2022

Summary

This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

Description

This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.

Details
Condition Dermatitis, Atopic
Treatment Placebo, SCD-044_Dose 1, SCD-044_Dose 2, SCD-044_Dose 3
Clinical Study IdentifierNCT04684485
SponsorSun Pharmaceutical Industries Limited
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged at least 18 years
Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka
Moderate to severe atopic dermatitis at Screening and Baseline

Exclusion Criteria

Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study
Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy
History or presence of uveitis
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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