Atopic Dermatitis
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Atopic Dermatitis
LP0133-1403

Research Trial for Atopic Dermatitis (22 Weeks)


Age: 18 Years

Adults aged 18 years or older with a diagnosis of chronic atopic dermatitis (AD), may qualify to participate. Individuals must have moderate to severe disease, with a history of AD for 1 year or more. AD must cover 5% or more body surface area. Recent documented history (within 6 months) of inadequate response to topical AD treatments or for whom topical AD treatments are otherwise medically inadvisable, is also required.

Participants will receive investigational oral medication (active study drug) or placebo, in tablet form. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 22 weeks and involve about 13 visits to the study centre.


Official Title

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

ClinicalTrials.gov ID

NCT04949841

Sponsor

LEO Pharma

Study Description

  • Brief Summary:

    LEO Pharma

  • Condition or Disease:

    Chronic Hand Eczema

  • Intervention/Treatment:

    Drug: Delgocitinib
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult,Older Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion Criteria:

Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator’s judgment, makes the participant inappropriate for the trial.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Stephen Shumack

Dermatologist

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