A phase 2b, randomised, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered LEO 138559 in adult subjects with moderate-to-severe atopic dermatitis (AD) - LP0145-2240

eo Pharma A/S0 sites250 target enrollmentJune 21, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: eo Pharma A/S
Enrollment: 250
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 21, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

eo Pharma A/S

Eligibility Criteria

Inclusion Criteria

•18\-75 years old (both included) at screening (Visit 1\)., At screening, diagnosis of \- AD as defined by the Hanifin and Rajka (1980\) criteria for AD. History of AD for \=1 year., Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with TCS (±TCI as appropriate) or for whom these topical AD treatments are medically inadvisable (e.g. due to important side effects or safety risks)., EASI score \=12 at screening and \=16 at baseline., vIGA\-AD score \=3 at screening and baseline., BSA of AD involvement \=10% at screening and baseline., ADSD Worst Itch score (weekly average) \=4 at baseline.

Exclusion Criteria

•History of clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject’s ability to participate in the trial. Clinically significant infections are defined as: \- a systemic infection. \- a serious skin infection requiring parenteral (IV or intramuscular) antibiotics, antiviral, or antifungal medication., Receipt of blood products within 28 days prior to screening., Treatment with: \- Any marketed or investigational biologic agents within 3 months or 5 half\-lives, whichever is longer, prior to baseline. \- Any cell\-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer., Treatment with TCS, TCI, topical PDE\-4 inhibitors, topical JAK inhibitors, or other medicated topical treatments within 7 days prior to baseline, Receipt of live attenuated vaccines 30 days prior to baseline., Non\-serious skin infection within 7 days prior to baseline., Presence of hepatitis B or C infection at screening., History of HIV infection or positive HIV serology at screening., Evidence of active or latent tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment., Women who are pregnant or breastfeeding., Previous exposure to fezakinumab (anti\-IL\-22 Ab)., Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), corticosteroids (steroid eyedrops and inhaled or intranasal steroids are allowed), or JAK inhibitors within 28 days or 5 half\-lives prior to baseline, whichever is longer., Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 4 weeks prior to baseline.