Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
- - Male or female patients.
- - 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.
- - Patients must be candidates for systemic PsO therapy.
- - 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.
- - 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).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Canada, Germany, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Experimental: Dose group A
Experimental: Dose group B
Experimental: Dose group C
Experimental: Dose group D
Placebo Comparator: Placebo
Experimental: Dose group V
Experimental: Dose group U
Placebo Comparator: Placebo W
Drug: - BI 730357
Drug: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.