Efficacy and safety of different doses of LEO 138559 subcutaneously in adult subjects with moderate to severe atopic dermatitis
Topic / Pathology
- interventional
- Biologic
Objectives
Phase 2b, randomized, double-blind, placebo-controlled, multi-center, parallel-group trial to assess the efficacy and safety of different doses of LEO 138559 administered subcutaneously in adult subjects with moderate-to-severe atopic dermatitis.
Testing different doses of the drug (LEO 138559) in the treatment of moderate to severe atopic dermatitis in adults. There will be 4 different doses, which will also be compared to a placebo. Each participant will be randomly assigned to receive one of the 4 doses of LEO 138559 or placebo.
The trial will last up to 36 weeks, comprising a screening period (up to 4 weeks), a treatment period (16 weeks) and a follow-up period (16 weeks). Participants will have 17 visits during the study. During the first 4 weeks of the treatment period, visits are weekly; during the following 12 weeks of the treatment period, visits are every 2 weeks. During the 16-week follow-up period, visits are every 4 weeks.
Participants will also complete a daily electronic diary on their atopic dermatitis and quality of life.
https://clinicaltrials.gov/study/NCT05923099?term=NCT05923099&rank=1
Sponsor
LEO PHARMA
Investigator
Dr Marie Jachiet
Critères d'inclusion
- History of AD for ≥1 year.
- Subjects with a recent history (within 12 months prior to selection) of documented inadequate response to treatment with topical corticosteroid(s) (±topical calcineurin inhibitor(s) (TCI) where applicable) or for whom such topical AD treatments are medically inadvisable.
- EASI score ≥12 at screening and ≥16 at baseline.
- vIGA-AD scale ≥3 at screening and baseline.
- Body surface area (BSA) of AD involvement ≥10% at selection and baseline.
- Atopic dermatitis symptom diary (ADSD) worst itch score (weekly average) ≥4 at baseline.
- For women of childbearing potential, highly effective contraception for the duration of the trial and for at least 18 weeks after the last IMP administration.
Critères de non-inclusion
- Major surgery within 8 weeks of selection, or planned surgery or hospitalization during trial period.
- Active dermatological condition likely to confound the diagnosis of AD or interfere with treatment evaluation (e.g. scabies, contact dermatitis, rosacea, urticaria or psoriasis).
- History of cancer, with the following exceptions: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or carcinoma in situ of the cervix are eligible provided the subject is in remission and curative treatment has been completed at least 12 months prior to selection.
- Subjects who have had other malignancies are eligible provided the subject is in remission and curative therapy has been completed at least 5 years prior to selection.
- History of immunodeficiency syndrome or current immunodeficiency syndrome.
- History of anaphylaxis following biological treatment.
- Skin infection within 7 days of study start.
- HBsAg positive or anti-HCV positive AND HCV RNA positive at screening.
- History of HIV infection or positive HIV serology at screening.
- Evidence of active or latent tuberculosis.
- ALT or AST levels ≥2.0 times ULN at screening.
- History of suicide attempt or significant risk of suicide
- Known or suspected hypersensitivity to any component of the investigational drug.
- Current or recent chronic alcohol or drug abuse
- Previous treatment with LEO 138559.
- Previous exposure to fezakinumab (Ab anti-IL-22).
- Systemic treatment with immunosuppressants, immunomodulators, retinoids, corticosteroids (steroid eye drops and inhaled or intranasal steroids are permitted) or JAK inhibitors within 28 days or 5 half-lives prior to study entry, whichever is longer.
- Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- Receipt of blood products within 28 days prior to screening.
- Treatment with :
- Any marketed or investigational biological agent within 3 months or 5 half-lives, whichever is longer, prior to the start of the study.
- Any cell-depleting agent, 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 topical drug therapies within 7 days prior to baseline.
- Live attenuated vaccines 30 days before the reference date.
Status
Ongoing
