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

March 11, 2024 updated by: Boehringer Ingelheim

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Multiple Rising Doses of BI 765250 Versus Placebo in Trial Participants With Moderate to Severe Plaque Psoriasis (Double-blind, Randomised, Placebo-controlled, Parallel-group Design)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Drug: Placebo
placebo
Experimental: BI 765250 very low dose group
Drug: BI 765250
BI 765250
Experimental: BI 765250 low dose group
Drug: BI 765250
BI 765250
Experimental: BI 765250 medium dose group
Drug: BI 765250
BI 765250
Experimental: BI 765250 high dose group
Drug: BI 765250
BI 765250

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of any adverse events
Time Frame: Up to Day 239
Up to Day 239

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ (Cmax,ss)
Time Frame: Up to Day 85
Up to Day 85
Time from last dosing to maximum concentration of the analyte in serum at steady state (tmax,ss)
Time Frame: Up to Day 85
Up to Day 85
Area under the concentration-time curve of the analyte in serum at steady state over a uniform dosing interval τ (AUCτ,ss)
Time Frame: Up to Day 85
Up to Day 85
Absolute change from baseline in the Static Physician's Global Assessment (sPGA) x Body Surface Area (BSA) score
Time Frame: At baseline and at week 12
At baseline and at week 12
Percentage change from baseline in the sPGA x BSA score
Time Frame: At baseline and at week 12
At baseline and at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

November 8, 2024

Study Completion (Estimated)

April 11, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1474-0002
  • 2021-006280-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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