Psoriasis
Conditions
Brief summary
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
Interventions
DRUGBI 730357
Film-coated tablet
Film-coated tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Woman Of Child Bearing 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. * Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and * for patients entering from Part 1 of trial 1407-0030 \--- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit * for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator * 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. * Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030). * Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial. * Any plan to receive a live vaccination during the 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. * Women who are pregnant, nursing, or who plan to become pregnant while in the trial. * Any documented active or suspected malignancy, 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 and tuberculosis. * Evidence of a disease (including known or suspected IBD, 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 (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but without specific plan), or active suicidal thought with plan and intent in the past. * Unwillingness to adhere to the rules of UV-light protection * Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days. | Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2. Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg). Period 2: Only patients who participated in period 2 are reported by dose sequence group. For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | At week 24. | Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome. 0= clear (no signs of psoriasis), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration). |
| Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | At week 24. | Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome. 0= clear (No signs of psoriasis), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration). |
| Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | At baseline and at week 24. | Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. 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. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100. The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) \*100, at all visits with PASI collected. |
| Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Up to 802 days. | The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported. The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome). A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not. |
| Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Up to 802 days. | The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported. The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome). A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not. |
| Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | Up to 802 days. | The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported. PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome. A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
This was a multicentre, long-term extension trial in patients with moderate-to-severe plaque psoriasis who completed treatment in the preceding trial 1407-0030 (NCT03635099). Patients rolling over from Part 1 of 1407-0030 remained on their blinded BI 730357 dose treatment, until the open label period of 1407-0005 started at Day 1 of week 13 (dose group 25-200 mg). Patients rolling over from Part 2 of 1407-0030 were assigned at visit 1 to receive open label treatment with 400 mg BI 737357.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Only subjects which met all inclusion and none of the exclusion criteria were included in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| 25 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357. | 2 |
| 50 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357. | 20 |
| 100 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357. | 16 |
| 200 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2). | 49 |
| 400 mg BI 730357 Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. | 78 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Period | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Double-blind Period | Other not stated below | 0 | 0 | 0 | 1 | 1 |
| Double-blind Period | Protocol Violation | 0 | 2 | 0 | 1 | 0 |
| Double-blind Period | Termination of treatment by sponsor | 0 | 0 | 0 | 0 | 35 |
| Double-blind Period | Withdrawal by Subject | 0 | 0 | 1 | 0 | 5 |
| Open Label Period (After Week 12) | Adverse Event | 0 | 0 | 1 | 1 | 0 |
| Open Label Period (After Week 12) | Covid-19 related, not due to Adverse event | 0 | 0 | 0 | 1 | 0 |
| Open Label Period (After Week 12) | Lost to Follow-up | 0 | 0 | 4 | 3 | 0 |
| Open Label Period (After Week 12) | Other not stated above | 0 | 0 | 0 | 1 | 1 |
| Open Label Period (After Week 12) | Termination of treatment by Sponsor | 0 | 0 | 23 | 31 | 35 |
| Open Label Period (After Week 12) | Withdrawal by Subject | 0 | 0 | 7 | 9 | 1 |
Baseline characteristics
| Characteristic | 25 mg BI 730357 | 50 mg BI 730357 | 100 mg BI 730357 | 200 mg BI 730357 | 400 mg BI 730357 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.0 Years STANDARD_DEVIATION 2.8 | 47.2 Years STANDARD_DEVIATION 18.3 | 58.1 Years STANDARD_DEVIATION 13.5 | 49.9 Years STANDARD_DEVIATION 13.3 | 44.5 Years STANDARD_DEVIATION 13.3 | 47.7 Years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 6 Participants | 2 Participants | 12 Participants | 23 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 14 Participants | 14 Participants | 37 Participants | 55 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 6 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 17 Participants | 13 Participants | 42 Participants | 64 Participants | 137 Participants |
| Sex: Female, Male Female | 0 Participants | 8 Participants | 7 Participants | 12 Participants | 22 Participants | 49 Participants |
| Sex: Female, Male Male | 2 Participants | 12 Participants | 9 Participants | 37 Participants | 56 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 20 | 0 / 36 | 0 / 72 | 0 / 78 |
| other Total, other adverse events | 0 / 2 | 3 / 20 | 11 / 36 | 15 / 72 | 1 / 78 |
| serious Total, serious adverse events | 0 / 2 | 1 / 20 | 3 / 36 | 3 / 72 | 0 / 78 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2. Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg). Period 2: Only patients who participated in period 2 are reported by dose sequence group. For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.
Time frame: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. For dose groups 25 mg - 200 mg BI, results are reported separately for period 1 and period 2. For dose group 400 mg BI, results are reported overall (period 1 + period 2).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mg BI 730357 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 6 Participants |
| 100 mg BI 730357 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 6 Participants |
| 200 mg BI 730357 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 10 Participants |
| 400 mg BI 730357 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 14 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 8 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 6 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 28 Participants |
Secondary
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response
The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported. PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome. A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
Time frame: Up to 802 days.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 1 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 2 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 0 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 23 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 12 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 1 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 2 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 1 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 1 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 1 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 1 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 1 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 1 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 1 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 2 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 5 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 0 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 4 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 2 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 13 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 1 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 12 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 3 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 2 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 5 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 2 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 4 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 6 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 0 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 3 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 0 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 5 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 2 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 0 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 9 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 1 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 1 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 3 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 6 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 1 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 3 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 0 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 21 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 12 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 7 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 12 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 12 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 32 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 11 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 46 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Loss of Response | 4 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Loss of Response | 2 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Responders | 21 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI75 Loss of Response | 5 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI50 Responders | 30 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI90 Responders | 10 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Loss of Response | 1 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response | PASI100 Responders | 4 Participants |
Secondary
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24
Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. 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. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100. The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) \*100, at all visits with PASI collected.
Time frame: At baseline and at week 24.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 1 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 4 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 1 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 3 Participants |
| 100 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 1 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 12 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 9 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 4 Participants |
| 200 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 2 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 2 Participants |
| 400 mg BI 730357 | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 2 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 2 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 3 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 8 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 3 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 33 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 10 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 23 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI75 | 6 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI90 | 5 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI100 | 2 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 | PASI50 | 9 Participants |
Secondary
Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24
Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome. 0= clear (no signs of psoriasis), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration).
Time frame: At week 24.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 1 Participants |
| 100 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 2 Participants |
| 200 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 5 Participants |
| 400 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 3 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 18 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 | 7 Participants |
Secondary
Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24
Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome. 0= clear (No signs of psoriasis), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration).
Time frame: At week 24.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 1 Participants |
| 100 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 1 Participants |
| 200 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 2 Participants |
| 400 mg BI 730357 | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 0 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 3 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 | 2 Participants |
Secondary
Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response
The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported. The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome). A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
Time frame: Up to 802 days.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 0 Participants |
| 200 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 13 Participants |
| 200 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 2 Participants |
| 400 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 0 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 1 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 3 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 9 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 4 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 3 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 3 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 6 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 2 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 18 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 32 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Loss of response | 3 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response | Resonders | 17 Participants |
Secondary
Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response
The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported. The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome). A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
Time frame: Up to 802 days.
Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 0 Participants |
| 25 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 50 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 1 Participants |
| 50 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 0 Participants |
| 100 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 200 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 1 Participants |
| 200 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 400 mg BI 730357 | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 0 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 1 Participants |
| 25 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 1 Participants |
| 25 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 2 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 4 Participants |
| 50 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 3 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 0 Participants |
| 50 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 1 Participants |
| 100 mg BI - 100 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 0 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 7 Participants |
| 100 mg BI - 100 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 12 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Loss of response | 1 Participants |
| 200 mg BI - 200 mg BI | Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response | Resonders | 4 Participants |