PsoriasisPhase 1NCT05728489
A Study to Test How Well Different Doses of BI 765250 Are Tolerated by People With a Skin Disease Called Plaque Psoriasis
A Phase 1 study testing BI 765250 in people with Psoriasis, run by Boehringer Ingelheim at 5 sites in 4 countries.
Trial 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 5 groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- BI 765250
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 27 Apr 2023to 24 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Romania2 sites
MONZA Medical Center
Bucharest, 011658
Emergency County Hospital, Arensia EM
Cluj-Napoca, 400347
Moldova1 site
Clinical Republican Hospital "Timofei Mosneaga"
Chisinau, MD-2025
About this study
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, 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 5 groups. Each group gets a different dose of BI 765250 or placebo as an infusion or injection for 12 weeks. 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 or 4 weeks. In total, every participant gets up to 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.
- Conditions
- Psoriasis
- Being tested
- BI 765250, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 765250Drug
BI 765250
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 765250 very low dose group | Experimental | Not described Receives: Drug: BI 765250 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| BI 765250 low dose group | Experimental | Not described Receives: Drug: BI 765250 |
| BI 765250 medium dose group | Experimental | Not described Receives: Drug: BI 765250 |
| BI 765250 high dose group | Experimental | Not described Receives: Drug: BI 765250 |
| BI 765250 very high dose group | Experimental | Not described Receives: Drug: BI 765250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any adverse events
Measured: Up to Day 239
Secondary outcomes (5)
Maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: Up to Day 85
Time from last dosing to maximum concentration of the analyte in serum at steady state (tmax,ss)
Measured: 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)
Measured: Up to Day 85
Absolute change from baseline in the Static Physician's Global Assessment (sPGA) x Body Surface Area (BSA) score
Measured: At baseline and at week 12
Percentage change from baseline in the sPGA x BSA score
Measured: At baseline and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start27 Apr 2023
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728489
- Sponsor's protocol ID
- 1474-0002
- Other IDs
- 2021-006280-25, 2024-512420-10-00, U1111-1308-0095
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Parallel-group Design)
- ClinicalTrials.gov ID
- NCT05728489
- Acronym / sponsor ID
- 1474-0002
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 5 groups. Each group gets a different dose of BI 765250 or placebo as an infusion or injection for 12 weeks. 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 or 4 weeks. In total, every participant gets up to 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BI 765250 very low dose group | Experimental | Drug: BI 765250 |
| Placebo group | Placebo comparator | Drug: Placebo |
| BI 765250 low dose group | Experimental | Drug: BI 765250 |
| BI 765250 medium dose group | Experimental | Drug: BI 765250 |
| BI 765250 high dose group | Experimental | Drug: BI 765250 |
| BI 765250 very high dose group | Experimental | Drug: BI 765250 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 mass index (BMI) <35 kg/m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 765250BI 765250 | Drug | BI 765250 high dose group, BI 765250 low dose group, BI 765250 medium dose group, BI 765250 very high dose group, BI 765250 very low dose group |
| Placeboplacebo | Drug | Placebo group |
Primary outcome
Occurrence of any adverse events
Time frame: Up to Day 239
5 secondary outcomes
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
Time from last dosing to maximum concentration of the analyte in serum at steady state (tmax,ss)
Time frame: 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
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
Percentage change from baseline in the sPGA x BSA score
Time frame: At baseline and at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 765250 in people with Psoriasis, run by Boehringer Ingelheim at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Romania, Bulgaria, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any adverse events (time frame: Up to Day 239). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.