PsoriasisPhase 2NCT03635099

This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is

A Phase 2 study testing BI 25 mg (fasted), BI 50 mg (fasted) and BI 100 mg (fasted) in people with Psoriasis, run by Boehringer Ingelheim at 34 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through 24 weeks of treatment 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 25 mg (fasted), BI 50 mg (fasted) and BI 100 mg (fasted)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 274 participants
Where: 34 sitesin 3 countries
Study dates: 17 Sep 2018to 26 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female patients. Woman Of Childbearing Potential (WoCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
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. Duration of diagnosis may be reported by the patient
Patients must be candidates for systemic PsO therapy.Moderate-to-severe plaque psoriasis:
BSA ≥10% and

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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

Who cannot join

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

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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. A patient can be re-screened if the patient was treated and is cured from the acute infection.
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).
Unwillingness to adhere to the rules of UV-light protection
Further exclusion criteria apply

Trial locations and contacts

34 sites in 3 countries.

Country

City, postcode or hospital

34 sites in 3 countries

United States16 sites

Hamilton Research
Alpharetta, Georgia, 30022
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Synexus
Cincinnati, Ohio, 45236
Menter Dermatology Research Institute
Dallas, Texas, 75246
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Center for Clinical Studies
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology Research Associates
Los Angeles, California, 90045
Icahn School of Medicine at Mount Sinai
New York, New York, 10003
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Health Concepts
Rapid City, South Dakota, 57702
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Southern California Dermatology Inc.
Santa Ana, California, 92701
Center for Clinical Studies
Webster, Texas, 77598

Other trials in United States

Canada11 sites

Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, E3B 1G9
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
DermEdge Research Inc.
Mississauga, Ontario, L5H 1G9
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Dr Chih-ho Hong Medical Inc
Surrey, British Columbia, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6

Other trials in Canada

Germany7 sites

Charité - Universitätsmedizin Berlin
Berlin, 10117
Studienzentrum im Jahrhunderthaus
Bochum, 44793
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
TFS Trial Form Support GmbH
Hamburg, 20537
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Universitätsklinikum Münster
Münster, 48149

Other trials in Germany

About this study

Official title: Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis

Conditions: Psoriasis
Being tested: Placebo (fasted), BI 25 mg (fasted), BI 50 mg (fasted), BI 100 mg (fasted), BI 200 mg (fasted)
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo (fasted)Drug
Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
BI 25 mg (fasted)Drug
25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
BI 50 mg (fasted)Drug
50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
BI 100 mg (fasted)Drug
100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
BI 200 mg (fasted)Drug
200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Placebo (fed)Drug
4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
BI 400 mg once daily (fed)Drug
4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
BI 200 mg twice daily, 400 mg total (fed)Drug
2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.

Study groups in NCT03635099
Study group	Role	What they receive
Part I - Placebo (fasted)	Placebo comparator	Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm. Receives: Drug: Placebo (fasted)
Part I - BI 25 mg (fasted)	Experimental	Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm. Receives: Drug: BI 25 mg (fasted)
Part I - BI 50 mg (fasted)	Experimental	Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm. Receives: Drug: BI 50 mg (fasted)
Part I - BI 100 mg (fasted)	Experimental	Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm. Receives: Drug: BI 100 mg (fasted)
Part I - BI 200 mg (fasted)	Experimental	Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Receives: Drug: BI 200 mg (fasted)
Part II - Placebo (fed)	Placebo comparator	Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks. Receives: Drug: Placebo (fed)
Part II - BI 400 mg once daily (fed)	Experimental	Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks. Receives: Drug: BI 400 mg once daily (fed)
Part II - BI 200 mg twice daily, 400 mg total (fed)	Experimental	Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks. Receives: Drug: BI 200 mg twice daily, 400 mg total (fed)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Measured: Assesment at week 12 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Measured: Assesment at week 12 of treatment

Secondary outcomes (8)

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 50 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction.
No hypothesis testing was planned or carried out for Part II.
Measured: Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 90 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 90 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 90.
Measured: Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 100 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 100 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 100.
Measured: Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at weeks 16, 20 and 24. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.
Measured: Assesment at week 16, 20 and 24 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12
Number of patients who achieved a static Physician's Global Assessment score of 'clear' (sPGA 0) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Measured: Assesment at week 12 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 16, 20 and 24. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Measured: Assesment at week 16, 20 and 24 of treatment
Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12
Overall change from baseline in psoriasis symptoms evaluated using the total score of the Psoriasis Symptoms Scale (PSS) at Week 12. The PSS is a four-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis.
Current symptom severity is assessed for a 24 hour recall period using a 5-point verbal rating scale, the PSS score ranges from 0 (none) to 4 (very severe). The symptom scores are added to an unweighted total score (range: 0 to 16).
Presented 'Mean' values are actually 'Adjusted Mean'. No hypothesis testing was planned or carried out for Part II.
Measured: Assesment at week 12 of treatment
Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12
Number of patients who achieved a Dermatology Life Quality Index score of 'no effect on patient's life' (DLQI 0/1) at Week 12. The DLQI is a subject-administered, ten-question, quality of life questionnaire covering 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Item scores range from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on subject's life. The higher the score, the more the quality of life is impaired. A 4-point change from baseline is considered a clinically important difference. No hypothesis testing was planned or carried out for Part II.
Measured: Assesment at week 12 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 201826 May 2021

First posted17 Aug 2018
Study start17 Sep 2018
Primary completion6 May 2021
Study completion26 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03635099
Sponsor's protocol ID: 1407-0030
Other IDs: 2017-004659-21, 2017
Status last verified: Jul 2022
First submitted: 15 Aug 2018
Last updated: 3 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
PubMed 39848568
Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
PubMed 36919398

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT03635099
Acronym / sponsor ID: 1407-0030
Conditions: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Sep 2018 (actual)
Primary completion: 6 May 2021 (actual)
Study completion: 26 May 2021 (actual)
First posted: 17 Aug 2018 (actual)
Results: Posted 2 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Part I - Placebo (fasted)	Placebo comparator	Drug: Placebo (fasted)Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Part I - BI 25 mg (fasted)	Experimental	Drug: BI 25 mg (fasted)Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Part I - BI 50 mg (fasted)	Experimental	Drug: BI 50 mg (fasted)Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Part I - BI 100 mg (fasted)	Experimental	Drug: BI 100 mg (fasted)Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Part I - BI 200 mg (fasted)	Experimental	Drug: BI 200 mg (fasted)Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Part II - Placebo (fed)	Placebo comparator	Drug: Placebo (fed)Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
Part II - BI 400 mg once daily (fed)	Experimental	Drug: BI 400 mg once daily (fed)Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
Part II - BI 200 mg twice daily, 400 mg total (fed)	Experimental	Drug: BI 200 mg twice daily, 400 mg total (fed)Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female patients. Woman Of Childbearing Potential (WoCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
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. Duration of diagnosis may be reported by the patient
Patients must be candidates for systemic PsO therapy.Moderate-to-severe plaque psoriasis:

Key exclusion criteria (20 listed)

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
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

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
Placebo (fasted)Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Drug	Part I - Placebo (fasted)
BI 25 mg (fasted)25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Drug	Part I - BI 25 mg (fasted)
BI 50 mg (fasted)50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Drug	Part I - BI 50 mg (fasted)
BI 100 mg (fasted)100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Drug	Part I - BI 100 mg (fasted)
BI 200 mg (fasted)200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Drug	Part I - BI 200 mg (fasted)
Placebo (fed)4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Drug	Part II - Placebo (fed)
BI 400 mg once daily (fed)4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Drug	Part II - BI 400 mg once daily (fed)
BI 200 mg twice daily, 400 mg total (fed)2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.	Drug	Part II - BI 200 mg twice daily, 400 mg total (fed)

Primary outcome

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12
Time frame: Assesment at week 12 of treatment
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. No statistical comparisons were planned or carried out for Part 2 of the trial.
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.
Time frame: Assesment at week 12 of treatment
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. No statistical comparisons were planned or carried out for Part 2 of the trial.

8 secondary outcomes

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12
Time frame: Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12
Time frame: Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12
Time frame: Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24
Time frame: Assesment at week 16, 20 and 24 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12
Time frame: Assesment at week 12 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24
Time frame: Assesment at week 16, 20 and 24 of treatment
Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12
Time frame: Assesment at week 12 of treatment
Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12
Time frame: Assesment at week 12 of treatment

Results and safety

Results posted to the registry on 2 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part I - Placebo (Fasted)	20	16
Part I - BI 25 mg (Fasted)	40	37
Part I - BI 50 mg (Fasted)	39	31
Part I - BI 100 mg (Fasted)	39	34
Part I - BI 200 mg (Fasted)	40	37
Part II - Placebo (Fed)	10	9
Part II - BI 400 mg Once Daily (Fed)	44	40
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	42	40

Primary outcome: Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12

Time frame: Assesment at week 12 of treatment. Count of participants. Unit: Participants

Measure	Part I - Placebo (Fasted) n = 20	Part I - BI 25 mg (Fasted) n = 40	Part I - BI 50 mg (Fasted) n = 39	Part I - BI 100 mg (Fasted) n = 39	Part I - BI 200 mg (Fasted) n = 40	Part II - Placebo (Fed) n = 10	Part II - BI 400 mg Once Daily (Fed) n = 43	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n = 42
Value	0	2	3	4	12	0	11	10

Part I - Placebo (Fasted) vs Part I - BI 25 mg (Fasted): Risk Difference (RD): 5.0 (95% CI -1.8 to 11.8), p = 0.3091, Chi-squared
Part I - Placebo (Fasted) vs Part I - BI 50 mg (Fasted): Risk Difference (RD): 7.7 (95% CI -0.7 to 16.1), p = 0.2030, Chi-squared
Part I - Placebo (Fasted) vs Part I - BI 100 mg (Fasted): Risk Difference (RD): 10.3 (95% CI 0.7 to 19.8), p = 0.1380, Chi-squared

Population analysed: Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.

Primary outcome: Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.

Time frame: Assesment at week 12 of treatment. Count of participants. Unit: Participants

Measure	Part I - Placebo (Fasted) n = 20	Part I - BI 25 mg (Fasted) n = 40	Part I - BI 50 mg (Fasted) n = 39	Part I - BI 100 mg (Fasted) n = 39	Part I - BI 200 mg (Fasted) n = 40	Part II - Placebo (Fed) n = 10	Part II - BI 400 mg Once Daily (Fed) n = 43	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n = 42
Value	0	1	3	2	11	0	11	10

Part I - Placebo (Fasted) vs Part I - BI 25 mg (Fasted): Risk Difference (RD): 2.5 (95% CI -2.3 to 7.3), p = 0.4758, Chi-squared
Part I - Placebo (Fasted) vs Part I - BI 50 mg (Fasted): Risk Difference (RD): 7.7 (95% CI -0.7 to 16.1), p = 0.2030, Chi-squared
Part I - Placebo (Fasted) vs Part I - BI 100 mg (Fasted): Risk Difference (RD): 5.1 (95% CI -1.8 to 12.1), p = 0.3028, Chi-squared

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part I - Period 1 - Fasted: Placebo	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Part I - Period 1 - Fasted: BI 25 mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Part I - Period 1 - Fasted: BI 50 mg	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Part I - Period 1 - Fasted: BI 100 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part I - Period 1 - Fasted: BI 200 mg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg	0 of 15 (0%)	9 of 15 (60%)	0 of 15
Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg	2 of 35 (5.7%)	15 of 35 (42.9%)	0 of 35
Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg	1 of 21 (4.8%)	13 of 21 (61.9%)	0 of 21
Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg	0 of 25 (0%)	12 of 25 (48%)	0 of 25
Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg	0 of 37 (0%)	18 of 37 (48.6%)	0 of 37
Part II - Placebo (Fed)	0 of 10 (0%)	5 of 10 (50%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39848568Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
Derived from this study: PubMed 36919398Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

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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.

34 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 25 mg (fasted), BI 50 mg (fasted) and BI 100 mg (fasted) in people with Psoriasis, run by Boehringer Ingelheim at 34 sites in 3 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 9 inclusion and 20 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12 (time frame: Assesment at week 12 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635099, which also lists 2 linked publications.

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 3 Aug 2022.