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

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BI 765250
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

BI 765250 very low dose group

Placebo group

BI 765250 low dose group

BI 765250 medium dose group

BI 765250 high dose group

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of any adverse events

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2023
Last Updated
July 28, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05728489
Brief Title
A Study to Test How Well Different Doses of BI 765250 Are Tolerated by People With a Skin Disease Called Plaque Psoriasis
Official Title
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, Parallelgroup Design)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
November 8, 2024 (Anticipated)
Study Completion Date
April 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BI 765250 very low dose group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
BI 765250 low dose group
Arm Type
Experimental
Arm Title
BI 765250 medium dose group
Arm Type
Experimental
Arm Title
BI 765250 high dose group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 765250
Intervention Description
BI 765250
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Occurrence of any adverse events
Time Frame
Up to Day 239
Secondary Outcome Measure Information:
Title
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
Title
Time from last dosing to maximum concentration of the analyte in serum at steady state (tmax,ss)
Time Frame
Up to Day 85
Title
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
Title
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
Title
Percentage change from baseline in the sPGA x BSA score
Time Frame
At baseline and at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
MBAL Sveta Sofia
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
024903378
Email
balgariya@bitrialsupport.com
Facility Name
Clinical Republican Hospital "Timofei Mosneaga"
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80060024
Email
moldova@bitrialsupport.com
Facility Name
MONZA Medical Center
City
Bucharest
ZIP/Postal Code
011658
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
Emergency County Hospital, Arensia EM
City
Cluj Napoca
ZIP/Postal Code
400347
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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

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