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

NCT ID: NCT03635099

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2021-05-26

Brief 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

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part I - 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.

Group Type: PLACEBO_COMPARATOR

Placebo (fasted)

Intervention Type: 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).

Part I - 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.

Group Type: EXPERIMENTAL

BI 25 mg (fasted)

Intervention Type: 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).

Part I - 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.

Group Type: EXPERIMENTAL

BI 50 mg (fasted)

Intervention Type: 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).

Part I - 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.

Group Type: EXPERIMENTAL

BI 100 mg (fasted)

Intervention Type: 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).

Part I - 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).

Group Type: EXPERIMENTAL

BI 200 mg (fasted)

Intervention Type: 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).

Part II - 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.

Group Type: PLACEBO_COMPARATOR

Placebo (fed)

Intervention Type: 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.

Part II - 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.

Group Type: EXPERIMENTAL

BI 400 mg once daily (fed)

Intervention Type: 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.

Part II - 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.

Group Type: EXPERIMENTAL

BI 200 mg twice daily, 400 mg total (fed)

Intervention Type: 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.

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Dermatology Research Associates

Los Angeles, California, United States

Southern California Dermatology Inc.

Santa Ana, California, United States

Hamilton Research

Alpharetta, Georgia, United States

Advanced Medical Research PC

Sandy Springs, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Synexus

Cincinnati, Ohio, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Dr Chih-ho Hong Medical Inc

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, Canada

The Guenther Dermatology Research Centre

London, Ontario, Canada

DermEdge Research Inc.

Mississauga, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

The Centre for Clinical Trials

Oakville, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

K. Papp Clinical Research Inc.

Waterloo, Ontario, Canada

XLR8 Medical Research Inc.

Windsor, Ontario, Canada

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Studienzentrum im Jahrhunderthaus

Bochum, , Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

TFS Trial Form Support GmbH

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Universitätsklinikum Münster

Münster, , Germany

Countries

United States; Canada; Germany

References

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.

Reference Type: DERIVED

PMID: 39848568 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36919398 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2017-004659-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1407-0030

Identifier Type: -

Identifier Source: org_study_id