A Study to Test How Well Different Doses of BI 765250 Are Tolerated by People With a Skin Disease Called Plaque Psoriasis
Psoriasis
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Female participants of non-childbearing potential and male participants Age 18 to 75 years (both inclusive) at the time of informed consent Diagnosis of chronic plaque psoriasis for at least 6 months prior to randomisation, as confirmed by their medical record or history Moderate to severe plaque psoriasis, as defined by: Body surface area (BSA) ≥5% and <30% Static Physician's Global Assessment (sPGA) ≥3 Target lesions suitable for skin biopsy Body mass index (BMI) <35 kg/m2 Male participants able to father a child 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 and instructions on the duration of their use is provided in the participant information Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Exclusion Criteria: Non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations Major surgery (major according to the investigator's assessment, e.g. hip replacement) performed within 16 weeks prior to randomisation or planned during the trial (i.e. until the End of Study Visit) Women of childbearing potential (WOCBP), breastfeeding women, and men unwilling or unable to use highly effective methods of birth control Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except: Treated (i.e. cured) basal cell or squamous cell in situ skin carcinomas Treated (i.e. cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of screening Live or attenuated vaccination ≤6 weeks prior to randomisation, or any plan to receive a live vaccination during the conduct of this trial until the End of Treatment Visit Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial Hepatic/renal impairment defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 Currently enrolled in an investigational drug or device study, or use of any investigational drug or device within 4 weeks prior to randomisation or 5 half-lives of the drug (whichever is longer) Further exclusion criteria apply
Sites / Locations
- MBAL Sveta SofiaRecruiting
- Clinical Republican Hospital "Timofei Mosneaga"Recruiting
- MONZA Medical CenterRecruiting
- Emergency County Hospital, Arensia EMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
BI 765250 very low dose group
Placebo group
BI 765250 low dose group
BI 765250 medium dose group
BI 765250 high dose group