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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000581-42 |
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Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.
Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.
Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
|
| Risankizumab | Experimental | Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo for Risankizumab | Drug | Subcutaneous (SC) Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear." | Baseline, Week 16 |
| Number of Participants With Treatment-Emergent Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 219197 | Glendale | Arizona | 85308 | United States | ||
| Burke Pharmaceutical Research /ID# 223349 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39208985 | Derived | Lebwohl M, Bukhalo M, Stein Gold L, Glick B, Llamas-Velasco M, Sanchez-Rivera S, Pan A, Zhan T, Drogaris L, Douglas K, St John G, Espaillat R, Bissonnette R. A randomized phase 3b study evaluating the safety and efficacy of risankizumab in adult patients with moderate-to-severe plaque psoriasis with non-pustular palmoplantar involvement. J Am Acad Dermatol. 2024 Dec;91(6):1150-1157. doi: 10.1016/j.jaad.2024.07.1521. Epub 2024 Aug 30. |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Eligible participants were randomized at the Baseline visit in a 1:1 ratio to receive either risankizumab 150 mg as a single SC injection, or matching placebo during the Double-blind Period. Study drug administration occurred at Baseline and Week 4. Starting at Week 16, participants received open-label risankizumab 150 mg once every 12 weeks (q12w) at Weeks 16, 28, and 40. The final efficacy evaluation took place at Week 52.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. |
| FG001 | Risankizumab | Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period (Baseline - Week 16) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2021 | Mar 18, 2024 |
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| Risankizumab |
| Drug |
Subcutaneous (SC) Injection |
|
|
| Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Baseline, Week 16 |
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease. | Baseline, Week 16 |
| Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Baseline, Week 16 |
| Hot Springs |
| Arkansas |
| 71913-6404 |
| United States |
| NW Arkansas Clinical Trials Center /ID# 231602 | Rogers | Arkansas | 72758 | United States |
| Dermatology Research Associates /ID# 219195 | Los Angeles | California | 90045 | United States |
| Integrative Skin Science and Research /ID# 219216 | Sacramento | California | 95815 | United States |
| Medderm Associates /ID# 219210 | San Diego | California | 92103 | United States |
| Colorado Center for Dermatology, PLLC /ID# 219223 | Centennial | Colorado | 80111-1724 | United States |
| Skin Care Research - Hollywood /ID# 219184 | Hollywood | Florida | 33021-6748 | United States |
| GSI Clinical Research, LLC /ID# 219175 | Margate | Florida | 33063 | United States |
| Savin Medical Group, LLC /ID# 227754 | Miami Lakes | Florida | 33014-2490 | United States |
| Lenus Research & Medical Group /ID# 219202 | Sweetwater | Florida | 33172 | United States |
| Hamilton Research, LLC /ID# 219224 | Alpharetta | Georgia | 30022 | United States |
| Arlington Dermatology /ID# 219211 | Rolling Meadows | Illinois | 60008 | United States |
| Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220 | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin, LLC /ID# 219219 | Indianapolis | Indiana | 46256 | United States |
| The Dermatology Center PSC - New Albany /ID# 219183 | New Albany | Indiana | 47150 | United States |
| Epiphany Dermatology of Kansas LLC /ID# 219208 | Overland Park | Kansas | 66210 | United States |
| Allcutis Research LLC /ID# 222272 | Methuen | Massachusetts | 01844-5864 | United States |
| David Fivenson, MD, PLC /ID# 219180 | Ann Arbor | Michigan | 48103 | United States |
| Henry Ford Medical Center /ID# 219205 | Detroit | Michigan | 48202-3046 | United States |
| Advanced Dermatology of the Midlands /ID# 219207 | Omaha | Nebraska | 68144-1105 | United States |
| Psoriasis Treatment Center of Central New Jersey /ID# 219201 | East Windsor | New Jersey | 08520 | United States |
| Forest Hills Dermatology Group /ID# 219200 | Kew Gardens | New York | 11415 | United States |
| Icahn School of Medicine at Mount Sinai /ID# 219206 | New York | New York | 10029-6504 | United States |
| ClinOhio Research Services /ID# 222298 | Columbus | Ohio | 43213-4440 | United States |
| University of Pittsburgh MC /ID# 219203 | Pittsburgh | Pennsylvania | 15260 | United States |
| Velocity Clinical Research-Providence /ID# 223350 | East Greenwich | Rhode Island | 02818 | United States |
| Palmetto Clinical Trial Services /ID# 222275 | Fountain Inn | South Carolina | 29644-1928 | United States |
| Palmetto Clinical Trial Services /ID# 222299 | Fountain Inn | South Carolina | 29644-1928 | United States |
| International Clinical Research - Tennessee LLC /ID# 220930 | Murfreesboro | Tennessee | 37130-2450 | United States |
| Menter Dermatology Res Inst /ID# 219161 | Dallas | Texas | 75246 | United States |
| Center for Clinical Studies - Houston (Binz) /ID# 219221 | Houston | Texas | 77004-8097 | United States |
| Advanced Clinical Research - Woseth Dermatology /ID# 224750 | Salt Lake City | Utah | 84117-4209 | United States |
| Virginia Clinical Research, Inc. /ID# 219181 | Norfolk | Virginia | 23507 | United States |
| Beacon Dermatology Inc /ID# 220940 | Calgary | Alberta | T3E 0B2 | Canada |
| Dr. Chih-ho Hong Medical Inc. /ID# 220941 | Surrey | British Columbia | V3R 6A7 | Canada |
| Dr. Irina Turchin PC Inc. /ID# 220938 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| NewLab Clinical Research Inc. /ID# 220934 | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936 | Newmarket | Ontario | L3Y 5G8 | Canada |
| Research Toronto /ID# 220939 | Toronto | Ontario | M4W 2N4 | Canada |
| Innovaderm Research Inc. /ID# 222126 | Montreal | Quebec | H2X 2V1 | Canada |
| Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935 | Québec | Quebec | G1V 4X7 | Canada |
| Dr. Samuel Sanchez PSC /ID# 218789 | Caguas | 00727 | Puerto Rico |
| Alma M. Cruz Santana, MD-Private practice /ID# 218790 | Carolina | 00985 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC /ID# 218788 | Rio Piedras | 00935 | Puerto Rico |
| Clinical Research Puerto Rico /ID# 218787 | San Juan | 00909 | Puerto Rico |
| GCM Medical Group, PSC /ID# 218786 | San Juan | 00917 | Puerto Rico |
| Hospital Universitario Basurto /ID# 220904 | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Universitario de la Princesa /ID# 224911 | Madrid | 28006 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 220908 | Madrid | 28034 | Spain |
| Hospital Regional Universitario de Malaga /ID# 220900 | Málaga | 29011 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 220907 | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia /ID# 220898 | Valencia | 46014 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 220903 | Valencia | 46026 | Spain |
| Hospital Clinico Universitario Lozano Blesa /ID# 222492 | Zaragoza | 50009 | Spain |
| FG002 | Placebo/Risankizumab | Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
| FG003 | Risankizumab/Risankizumab | Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Period (Week 16 - Week 52) |
|
|
Intent to Treat Population: all randomized participants, analyzed according to the treatment groups to which they were randomized during the Double-blind Period
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
| BG001 | Risankizumab | Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
| BG002 | 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 | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Baseline ppIGA score | The Palmoplantar Investigator's Global Assessment (ppIGA) is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity. | Count of Participants | Participants | No |
| ||||||||||||||
| Baseline PPASI score | The Palmoplantar Psoriasis Area and Severity Index (PPASI) is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline sPGA score | The Static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease. | Count of Participants | Participants | No |
|
| 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 | Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear." | Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | All participants who were randomized and received at least 1 dose of study drug in the Double-blind Period; all participants who received at least 1 dose of study drug in the Open-label Period. | Posted | Count of Participants | Participants | No | From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks) |
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| Secondary | Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease. | Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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| Secondary | Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. | Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
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All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Double-blind Period) | Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period. | 0 | 87 | 0 | 87 | 2 | 87 |
| EG001 | Risankizumab (Double-blind Period) | Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period. | 0 | 87 | 5 | 87 | 2 | 87 |
| EG002 | Placebo/Risankizumab (Open-label Period) | Participants received placebo injections during the Double-blind Period and risankizumab injections during the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period. | 0 | 81 | 0 | 81 | 8 | 81 |
| EG003 | Risankizumab/Risankizumab (Open-label Period) | Participants received risankizumab injections during both the Double-blind Period and the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period. | 1 | 84 | 5 | 84 | 12 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2023 | Mar 18, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601773 | risankizumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Lack of Efficacy |
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| Other, not specified |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Almost Clear |
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| Mild |
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| Moderate |
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| Severe |
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| Almost Clear |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Risankizumab |
Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. |
| OG002 | Placebo/Risankizumab | Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
| OG003 | Risankizumab/Risankizumab | Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
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