An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.

  • STATUS
    Recruiting
  • End date
    Oct 21, 2022
  • participants needed
    52
  • sponsor
    LEO Pharma
Updated on 19 September 2021
LEO Investigational Site (1.9 mi away) Contact
+10 other location
eczema
topical agents

Summary

This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD).

The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient.

The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.

Details
Condition Eczema, ATOPIC DERMATITIS, Dermatitis
Treatment LEO 138559, LEO 138559 placebo
Clinical Study IdentifierNCT04922021
SponsorLEO Pharma
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-64 years old (both included) at screening
Diagnosis of atopic dermatitis (AD) (as defined by the American Academy of Dermatology Consensus Criteria) that has been present for 1 year prior to screening
Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable
Eczema Area and Severity Index (EASI) score 12 at screening and 16 at baseline
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score 3 at screening and baseline
Body surface area (BSA) of AD involvement 10% at screening and baseline
Worst Daily Pruritus Numeric Rating Scale (NRS, weekly average) of 3 points at baseline

Exclusion Criteria

Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomization, whichever is longer
Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomization, whichever is longer
Treatment with topical corticosteroid(s) (TCS), topical calcineurin inhibitor(s) (TCI), topical phosphodiesterase-4 (PDE-4) inhibitor, or other topical prescription treatments within 1 week prior to randomization
Treatment with a live (attenuated) vaccine within 12 weeks prior to randomization
Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomization that may compromise the safety of the subject
Skin infection within 1 week prior to the baseline visit
Presence of hepatitis B or C infection at screening
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
Participant has a positive or indeterminate test for tuberculosis at screening
Participant is pregnant or lactating
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