Clinical trial NCT04922021: An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-site, Proof of Concept Trial to Evaluate the Efficacy and Safety of LEO 138559 in Adult Subjects With Moderate to Severe Atopic Dermatitis (AD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 18-64 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.

Primary outcomes:
measure: Change in EASI Score From Baseline to Week 16
timeFrame: Week 0 to Week 16
Secondary outcomes:
measure: Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
timeFrame: Week 0 to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: LEO Pharma Investigational Site
state: Alabama
city: Fountain Valley
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Doral
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Hialeah
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Markham
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Dresden
country: Germany
facility: LEO Pharma Investigational Site
city: Leipzig
country: Germany
facility: LEO Pharma Investigational Site
city: Lübeck
country: Germany
facility: LEO Pharma Investigational Site
city: Krakow
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Rzeszów
country: Poland
facility: LEO Pharma nvestigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: