A Study to Test How Well Different Doses of BI 765250 Are Tolerated by People With a Skin Disease Called Plaque Psoriasis

Study Purpose

This study is open to adults with plaque psoriasis. The main purpose of this study is to find out whether people with plaque psoriasis can tolerate a medicine called BI 765250. Another purpose is to check whether BI 765250 can improve participants' skin condition. Participants are divided into 4 groups. Each group gets a different dose of BI 765250 or placebo as an infusion or injection. Placebo infusions and injections look like BI 765250 but do not contain any medicine. It is decided by chance, who gets BI 765250 and who gets placebo. During the first 2 weeks, participants get the study medicine as an infusion into a vein once a week. Afterwards, they get the study medicine as an injection under the skin every 2 weeks. In total, every participant gets 5 injections. Participants are in the study for about 8 months. During this time, they visit the study site 23 times. On 2 of the visits, participants stay overnight at the study site, once for 2 nights and once for 1 night. The doctors collect information on any health problems of the participants. They also regularly check participants' skin condition.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.
  • - 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: - Hepatic impairment defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
Trial participants with Gilbert´s syndrome can be included unless total bilirubin elevation was >5-fold ULN at screening visit and unless proportions of bilirubin fractions are inconsistent with diagnosis of Gilbert´s syndrome.
  • - 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

Trial Details

Trial ID:

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.

NCT05728489
Phase

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.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Georgia, Moldova, Republic of, Romania
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: BI 765250 very low dose group

Placebo Comparator: Placebo group

Experimental: BI 765250 low dose group

Experimental: BI 765250 medium dose group

Experimental: BI 765250 high dose group

Interventions

Drug: - BI 765250

BI 765250

Drug: - Placebo

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.

International Sites

MBAL Sveta Sofia, Sofia, Bulgaria

Status

Recruiting

Address

MBAL Sveta Sofia

Sofia, , 1404

Site Contact

Boehringer Ingelheim

balgariya@bitrialsupport.com

024903378

"ARENSIA Exploratory Medicine" LLC, Tbilisi, Georgia

Status

Recruiting

Address

"ARENSIA Exploratory Medicine" LLC

Tbilisi, , 0112

Site Contact

Boehringer Ingelheim

sakartvelo@bitrialsupport.com

800008086

Chisinau, Moldova, Republic of

Status

Recruiting

Address

Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, , MD-2025

Site Contact

Boehringer Ingelheim

moldova@bitrialsupport.com

80060024

MONZA Medical Center, Bucharest, Romania

Status

Recruiting

Address

MONZA Medical Center

Bucharest, , 011658

Site Contact

Boehringer Ingelheim

romania@bitrialsupport.com

0800895209

Emergency County Hospital, Arensia EM, Cluj Napoca, Romania

Status

Recruiting

Address

Emergency County Hospital, Arensia EM

Cluj Napoca, , 400347

Site Contact

Boehringer Ingelheim

romania@bitrialsupport.com

0800895209

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.