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Company Decision
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Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.
Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.
Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.
There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. |
|
| 75 mg Cedirogant | Experimental | Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. |
|
| 150 mg Cedirogant | Experimental | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
|
| 375 mg Cedirogant | Placebo Comparator | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cedirogant | Drug | Capsule, Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. |
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Inclusion Criteria:
- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Dermatology /ID# 238563 | Birmingham | Alabama | 35233 | United States | ||
| Medical Dermatology Specialist /ID# 238518 |
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/
ITT population: all randomized participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. |
| FG001 | 75 mg Cedirogant | Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 13, 2022 | Nov 6, 2023 |
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| Placebo | Drug | Capsule, Oral |
|
| At Week 16 |
| Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 16 |
| Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 16 |
| Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 16 |
| Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline | The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. | Baseline, Week 16 |
| Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline | The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable." | Baseline, Week 16 |
| Phoenix |
| Arizona |
| 85006-2722 |
| United States |
| Arkansas Research Trials, LLC /ID# 238687 | North Little Rock | Arkansas | 72117 | United States |
| Encino Research Center /ID# 245950 | Encino | California | 91436 | United States |
| Velocity Clinical Research, Inc. /ID# 239536 | North Hollywood | California | 91606 | United States |
| Medderm Associates /ID# 238834 | San Diego | California | 92103 | United States |
| Lakes Research, LLC /ID# 238831 | Miami | Florida | 33014 | United States |
| Florida International Rsrch cr /ID# 245959 | Miami | Florida | 33173 | United States |
| Lenus Research & Medical Group /ID# 238695 | Sweetwater | Florida | 33172 | United States |
| Advanced Clinical Research Institute /ID# 238697 | Tampa | Florida | 33607-6429 | United States |
| Clinical Research Trials of Florida, Inc. /ID# 238709 | Tampa | Florida | 33607 | United States |
| ForCare Clinical Research /ID# 238856 | Tampa | Florida | 33613-1244 | United States |
| Cleaver Medical Group Dermatology - Dawsonville /ID# 246327 | Dawsonville | Georgia | 30534-6369 | United States |
| Marietta Dermatology Clinical Research /ID# 238679 | Marietta | Georgia | 30060-1047 | United States |
| Arlington Dermatology /ID# 238701 | Rolling Meadows | Illinois | 60008 | United States |
| Dawes Fretzin, LLC /ID# 238704 | Indianapolis | Indiana | 46256 | United States |
| Zel Skin & Laser Specialists - Edina /ID# 238714 | Edina | Minnesota | 55424-1200 | United States |
| Skin Specialists, PC /ID# 238514 | Omaha | Nebraska | 68144 | United States |
| Forest Hills Dermatology Group /ID# 238708 | Kew Gardens | New York | 11415 | United States |
| Buffalo Medical Group /ID# 239068 | Williamsville | New York | 14221 | United States |
| Darst Dermatology /ID# 238677 | Charlotte | North Carolina | 28277 | United States |
| Wilmington Dermatology Center /ID# 246445 | Wilmington | North Carolina | 28403 | United States |
| Univ Hosp Cleveland /ID# 245953 | Cleveland | Ohio | 44106 | United States |
| Dermatologists of Southwest Ohio, Inc /ID# 238939 | Mason | Ohio | 45040-4520 | United States |
| Oregon Dermatology and Research Center /ID# 238823 | Portland | Oregon | 97210 | United States |
| University of Pittsburgh MC /ID# 246170 | Pittsburgh | Pennsylvania | 15260 | United States |
| Clinical Partners, LLC /ID# 238620 | Johnston | Rhode Island | 02919 | United States |
| Clinical Research Center of the Carolinas /ID# 238827 | Charleston | South Carolina | 29407 | United States |
| Health Concepts /ID# 238510 | Rapid City | South Dakota | 57702 | United States |
| Tennessee Clinical Research Center /ID# 238682 | Nashville | Tennessee | 37215-2885 | United States |
| Arlington Research Center, Inc /ID# 244171 | Arlington | Texas | 76011 | United States |
| Orion Clinical Research /ID# 238619 | Austin | Texas | 78759-4100 | United States |
| Bellaire Dermatology Associates /ID# 247865 | Bellaire | Texas | 77401 | United States |
| Center for Clinical Studies - Houston (Binz) /ID# 243700 | Houston | Texas | 77004-8097 | United States |
| Progressive Clinical Research /ID# 238565 | San Antonio | Texas | 78229 | United States |
| Dermatology Specialists of Spokane /ID# 238809 | Spokane | Washington | 99202 | United States |
| West Virginia Research /ID# 238517 | Morgantown | West Virginia | 26505-0589 | United States |
| Dr. Chih-ho Hong Medical Inc. /ID# 238864 | Surrey | British Columbia | V3R 6A7 | Canada |
| Wiseman Dermatology Research /ID# 238867 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center /ID# 238861 | Barrie | Ontario | L4M 7G1 | Canada |
| Dr. Wei Jing Loo Medicine Prof /ID# 238865 | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc. /ID# 243199 | Markham | Ontario | L3P 1X2 | Canada |
| K. Papp Clinical Research /ID# 239695 | Waterloo | Ontario | N2J 1C4 | Canada |
| Nagoya City University Hospital /ID# 239286 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Takagi Dermatology Clinic /ID# 239274 | Obihiro-shi | Hokkaido | 080-0013 | Japan |
| JR Sapporo Hospital /ID# 239277 | Sapporo | Hokkaido | 060-0033 | Japan |
| Mie University Hospital /ID# 239275 | Tsu | Mie-ken | 514-8507 | Japan |
| Okayama University Hospital /ID# 239285 | Okayama | Okayama-ken | 700-8558 | Japan |
| Kansai Medical University Hospital /ID# 239278 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Hamamatsu University Hospital /ID# 239346 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| The Jikei University Hospital /ID# 239319 | Minato-ku | Tokyo | 105-8471 | Japan |
| NTT Medical Center Tokyo /ID# 239287 | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| Tokyo Medical University Hospital /ID# 239320 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| FG002 | 150 mg Cedirogant | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
| FG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT population: all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. |
| BG001 | 75 mg Cedirogant | Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. |
| BG002 | 150 mg Cedirogant | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
| BG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
| BG004 | 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 |
| |||||||||||||||
| Psoriasis Area and Severity Index (PASI) Score at Baseline | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Static Physicians Global Assessment (sPGA)--No. of participants with score of 3 or 4 at Baseline | 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 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
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| Secondary | Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline | The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline | The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable." | ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 16 |
|
All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
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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 | Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. | 0 | 39 | 0 | 39 | 8 | 39 |
| EG001 | 75 mg Cedirogant | Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. | 0 | 39 | 0 | 39 | 4 | 39 |
| EG002 | 150 mg Cedirogant | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. | 0 | 39 | 1 | 39 | 9 | 39 |
| EG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. | 0 | 39 | 2 | 39 | 16 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
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 | Dec 15, 2022 | Nov 6, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| 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 |
|
| Baseline score of 4 |
|
| OG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
|
|
| OG002 | 150 mg Cedirogant | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
| OG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
|
|
| OG002 | 150 mg Cedirogant | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
| OG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
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| OG002 | 150 mg Cedirogant | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
| OG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
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Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.
| OG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
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| OG003 | 375 mg Cedirogant | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
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