Atopic Dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : BI 655130
INN of investigational material : Spesolimab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 18 to 75 years of age at screening 2. Diagnosis of atopic dermatitis for at least 1 year 3. Moderate to severe atopic dermatitis defined as: - At least 10% Body Surface Area (BSA) of atopic dermatitis involvement at screening and baseline - Eczema Area and Severity Index (EASI) of at least 12 at screening and at least 16 at baseline - Investigator Global Assessment (IGA) of at least 3 at screening and baseline 4. Documented history of inadequate response to topical corticosteroid as judged by the investigator 5. Willing to use a standard emollient for the duration of the study 6. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion criteria
Exclusion criteria: 1. Use of topical corticosteroids or other agents for atopic dermatitis within 7 days prior to first dose of trial treatment. 2. Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment. 3. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the last study drug administration 4. Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. 5. Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator. 6. History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients. 7. Active systemic infections (Fungal and bacterial disease) during the last 2 weeks prior to first drug administration, per investigator assessment. 8. Relevant chronic or acute infections (exception: common cold) including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Number of patients with drug related Adverse Events (AEs) - Absolute change from baseline in Eczema Area and Severity Index (EASI) at Week 4 - Percentage change from baseline in Eczema Area and Severity Index (EASI) at Week 4 - Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16 - Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16 - Change from baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4 and 16 - Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16 | — |
Countries
Japan, North America
Outcome results
None listed