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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003487-31 | EudraCT Number |
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Due to company decision.
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To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg BI 730357 | Experimental | 25 mg BI 730357 + placebo under fasted conditions. |
|
| 50 mg BI 730357 | Experimental | 50 mg BI 730357 + placebo under fasted conditions. |
|
| 100 mg BI 730357 | Experimental | 100 mg BI 730357 + placebo under fasted conditions. |
|
| 200 mg BI 730357 | Experimental | 200 mg BI 730357 + placebo under fasted conditions |
|
| 400 mg BI 730357 | Experimental | 400 mg BI 730357 + placebo under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 730357 | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| Dermatology Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39848568 | Derived | Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21. | |
| 36919398 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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'.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Double-blind Period |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2020 | Jun 14, 2022 |
Not provided
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| Placebo to match BI 730357 | Drug | Film-coated tablet |
|
| At baseline and at week 24. |
| 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),
| At week 24. |
| 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),
| At week 24. |
| 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. | Up to 802 days. |
| 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. | Up to 802 days. |
| 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. | Up to 802 days. |
| Los Angeles |
| California |
| 90045 |
| United States |
| Southern California Dermatology Inc. | Santa Ana | California | 92701 | United States |
| Hamilton Research | Alpharetta | Georgia | 30022 | United States |
| Advanced Medical Research PC | Sandy Springs | Georgia | 30328 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| The Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10003 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Menter Dermatology Research Institute | Dallas | Texas | 75246 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Dr Chih-ho Hong Medical Inc | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Dr. Irina Turchin PC Inc. | Fredericton | New Brunswick | E3B 1G9 | Canada |
| The Guenther Dermatology Research Centre | London | Ontario | N6A 3H7 | Canada |
| DermEdge Research Inc. | Mississauga | Ontario | L5H 1G9 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| The Centre for Clinical Trials | Oakville | Ontario | L6J 7W5 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| K. Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research Inc. | Windsor | Ontario | N8W 1E6 | Canada |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| TFS Trial Form Support GmbH | Hamburg | 20537 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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). |
| FG004 | 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. |
|
| COMPLETED | Completed week 12 |
|
| NOT COMPLETED |
|
|
| Open Label Period (After Week 12) |
|
|
Treated Set (TS): All patients who received at least one dose of treatment in the extension trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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). |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | 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. |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | At baseline and at week 24. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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),
| 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. | Posted | Count of Participants | Participants | At week 24. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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),
| 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. | Posted | Count of Participants | Participants | At week 24. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Participants | Up to 802 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Participants | Up to 802 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Participants | Up to 802 days. |
|
From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days.
Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25 mg BI 730357 (Actual Dose) | Patients received 25 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 25 mg BI 730357. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | 50 mg BI 730357 (Actual Dose) | Patients received 50 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 50 mg BI 730357. | 0 | 20 | 1 | 20 | 3 | 20 |
| EG002 | 100 mg BI 730357 BI (Actual Dose) | Patients who received 100 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 100 mg BI 730357. | 0 | 36 | 3 | 36 | 11 | 36 |
| EG003 | 200 mg BI 730357 (Actual Dose) | Patients received 200 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 200 mg BI 730357. | 0 | 72 | 3 | 72 | 15 | 72 |
| EG004 | 400 mg BI 730357 (Actual Dose) | Patients received 400 mg of BI 730357 orally once daily under fed conditions throughout the trial. This group includes all subjects who actually received 400 mg BI 730357. | 0 | 78 | 0 | 78 | 1 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
The trial was ended prematurely by the sponsor. As a consequence, primary and secondary endpoints were limited to descriptive outcome measures. The recruitment was completed as planned.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2021 | Jun 14, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Covid-19 related, not due to Adverse event |
|
| Other not stated above |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | 25 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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 and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2). |
| OG002 | 50 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG003 | 50 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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 and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2). |
| OG004 | 100 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG005 | 100 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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 and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2). |
| OG006 | 200 mg BI - 200 mg BI | 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 reassigned to the 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). |
| OG007 | 400 mg BI - 400 mg BI | 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. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks. |
|
|
| OG002 | 50 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG003 | 50 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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 and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2). |
| OG004 | 100 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG005 | 100 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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 and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2). |
| OG006 | 200 mg BI - 200 mg BI | 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 reassigned to the 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). |
| OG007 | 400 mg BI - 400 mg BI | 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. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks. |
|
|
| OG002 | 50 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG003 | 50 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG004 | 100 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG005 | 100 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG006 | 200 mg BI - 200 mg BI | 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 reassigned to the 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). |
| OG007 | 400 mg BI - 400 mg BI | 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. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks. |
|
|
| OG001 | 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. |
| OG002 | 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). |
| OG003 | 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. |
| OG004 | 25 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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). |
| OG005 | 25 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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). |
| OG006 | 50 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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) |
| OG007 | 50 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG008 | 100 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG009 | 100 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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 1of 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). |
| OG010 | 200 mg BI - 200 mg BI | 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 reassigned to the 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). |
| OG011 | 400 mg BI - 400 mg BI | 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. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks. |
|
|
| OG001 | 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. |
| OG002 | 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). |
| OG003 | 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. |
| OG004 | 25 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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). |
| OG005 | 25 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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). |
| OG006 | 50 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG007 | 50 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG008 | 100 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG009 | 100 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG010 | 200 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG011 | 400 mg BI - 400 mg BI | 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. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks. |
|
|
| OG001 | 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. |
| OG002 | 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). |
| OG003 | 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. |
| OG004 | 25 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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). |
| OG005 | 25 mg BI - 100 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 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). |
| OG006 | 50 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG007 | 50 mg BI - 100 mg BI - 200 mg | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 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). |
| OG008 | 100 mg BI - 100 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG009 | 100 mg BI - 100 mg - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG010 | 200 mg BI - 200 mg BI | Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 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). |
| OG011 | 400 mg BI - 400 mg BI | 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. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks. |
|
|