This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo (fasted); BI 25 mg (fasted); BI 50 mg (fasted); BI 100 mg (fasted); BI 200 mg (fasted); Placebo (fed); BI 400 mg once daily (fed); BI 200 mg twice daily, 400 mg total (fed)
Intervention description: Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).; 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).; 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).; 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).; 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).; 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.; 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.; 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and
      Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety
      Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through
      24 weeks of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients. Woman Of Childbearing Potential (WoCBP) must be ready and
             able to use highly effective methods of birth control per International Conference on
             Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year
             when used consistently and correctly from date of screening until 4 weeks after last
             treatment in this trial. A list of contraception methods meeting these criteria is
             provided in the patient information.

          -  Age 18 to 75 years (both inclusive) at screening

          -  BMI < 35 kg/m2 at screening

          -  Diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at
             least 6 months before the first administration of study drug. Duration of diagnosis
             may be reported by the patient

          -  Patients must be candidates for systemic PsO therapy.Moderate-to-severe plaque
             psoriasis:

               -  BSA ≥10% and

               -  PASI ≥12 and

               -  sPGA moderate or severe

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial

        Exclusion Criteria:

          -  Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current
             druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta
             blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases
             (including but not limited to Inflammatory bowel disease (IBD)) other than PsO that
             might confound trial evaluations

          -  Previous enrolment in this trial or previous exposure to BI 730357.

          -  Current enrollment in another investigational device or drug trial, or is less than 30
             days (from randomisation) since ending another investigational device or drug
             trial(s), or receipt of other investigational treatment(s).

          -  Use of

               -  any biologic agent within 12 weeks, or

               -  any anti IL-23 biologic agent within 24 weeks prior to randomisation, or

               -  systemic anti-psoriatic medications or phototherapy within 4 weeks prior to
                  randomisation, or

               -  topical anti-psoriasis medications within 2 weeks prior to randomisation

          -  Receipt of a live vaccination within 12 weeks prior to randomisation (visit 2), or any
             plan to receive a live vaccination during the conduct of this trial

          -  Patients 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

          -  Patients not expected to comply with the protocol requirements or not expected to
             complete the trial as scheduled.

          -  Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,
             makes the patient an unreliable trial participant or unlikely to complete the trial.

          -  Major surgery (major according to the investigator's assessment) performed within 12
             weeks prior to randomisation or planned within 12 months after screening, e.g., hip
             replacement

          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial

          -  Any documented active or suspected malignancy or history of malignancy within 5 years
             prior to screening, except appropriately treated basal cell carcinoma of the skin,
             squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix

          -  Relevant chronic or acute infections including human immunodeficiency virus (HIV),
             viral hepatitis, candidiasis and tuberculosis. A patient can be re-screened if the
             patient was treated and is cured from the acute infection.

          -  Evidence of a current or previous disease (including known or suspected IBD, and
             cardiovascular disease), or medical finding that in the opinion of the investigator is
             clinically significant and would make the study participant unreliable to adhere to
             the protocol or to complete the trial, compromise the safety of the patient, or
             compromise the quality of the data.

          -  Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating
             Scale (CSSRS) in the past 3 months (i.e., active suicidal thought with intent but
             without specific plan, or active suicidal thought with plan and intent).

          -  Unwillingness to adhere to the rules of UV-light protection

          -  Further exclusion criteria apply