Back to resultsThis Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo (fasted)
BI 25 mg (fasted)
BI 50 mg (fasted)
BI 100 mg (fasted)
BI 200 mg (fasted)
Placebo (fed)
BI 400 mg once daily (fed)
BI 200 mg twice daily, 400 mg total (fed)
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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
- Further exclusion criteria apply
Sites / Locations
- Total Skin and Beauty Dermatology Center, PC
- Dermatology Research Associates
- Southern California Dermatology Inc.
- Hamilton Research
- Advanced Medical Research PC
- Dawes Fretzin Clinical Research Group, LLC
- The Psoriasis Treatment Center of Central New Jersey
- Icahn School of Medicine at Mount Sinai
- Synexus
- Clinical Partners, LLC
- Clinical Research Center of the Carolinas
- Health Concepts
- Menter Dermatology Research Institute
- Center for Clinical Studies
- Center for Clinical Studies
- Virginia Clinical Research, Inc.
- Dr Chih-ho Hong Medical Inc
- Enverus Medical Research
- Dr. Irina Turchin PC Inc.
- The Guenther Dermatology Research Centre
- DermEdge Research Inc.
- North Bay Dermatology Centre
- The Centre for Clinical Trials
- SKiN Centre for Dermatology
- The Centre for Dermatology
- K. Papp Clinical Research Inc.
- XLR8 Medical Research Inc.
- Charité - Universitätsmedizin Berlin
- Studienzentrum im Jahrhunderthaus
- Universitätsklinikum Frankfurt
- TFS Trial Form Support GmbH
- Universitätsklinikum Heidelberg
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
- Universitätsklinikum Münster
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Part I - Placebo (fasted)
Part I - BI 25 mg (fasted)
Part I - BI 50 mg (fasted)
Part I - BI 100 mg (fasted)
Part I - BI 200 mg (fasted)
Part II - Placebo (fed)
Part II - BI 400 mg once daily (fed)
Part II - BI 200 mg twice daily, 400 mg total (fed)
Arm Description
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03635099
Brief Title
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
Official Title
Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
May 6, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)
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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part I - Placebo (fasted)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Part I - BI 25 mg (fasted)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part I - BI 50 mg (fasted)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part I - BI 100 mg (fasted)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part I - BI 200 mg (fasted)
Arm Type
Experimental
Arm Description
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).
Arm Title
Part II - Placebo (fed)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Part II - BI 400 mg once daily (fed)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part II - BI 200 mg twice daily, 400 mg total (fed)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (fasted)
Intervention Description
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
Intervention Name(s)
BI 25 mg (fasted)
Intervention Description
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
Intervention Name(s)
BI 50 mg (fasted)
Intervention Description
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
Intervention Name(s)
BI 100 mg (fasted)
Intervention Description
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
Intervention Name(s)
BI 200 mg (fasted)
Intervention Description
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
Intervention Name(s)
Placebo (fed)
Intervention Description
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
Intervention Name(s)
BI 400 mg once daily (fed)
Intervention Description
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
Intervention Name(s)
BI 200 mg twice daily, 400 mg total (fed)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
Title
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.
Description
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.
Time Frame
Assesment at week 12 of treatment
Secondary Outcome Measure Information:
Title
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
Title
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
Title
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
Title
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24
Description
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.
Time Frame
Assesment at week 16, 20 and 24 of treatment
Title
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
Title
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
Description
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.
Time Frame
Assesment at week 16, 20 and 24 of treatment
Title
Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
Title
Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12
Description
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.
Time Frame
Assesment at week 12 of treatment
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:
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
Further exclusion criteria apply
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Southern California Dermatology Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Hamilton Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Synexus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dr Chih-ho Hong Medical Inc
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Dr. Irina Turchin PC Inc.
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
DermEdge Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
The Centre for Clinical Trials
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
K. Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
XLR8 Medical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Studienzentrum im Jahrhunderthaus
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com
Description
Related Info
Learn more about this trial
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
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