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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001687-36 | EudraCT Number | ||
| 1311.13 | Other Identifier | Boehringer Ingelheim |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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The primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.
Participants who had successfully completed Study 1311.2 (NCT02054481; the lead-in study) and met the eligibility criteria for Study M16-009 (extension study) had the option to enter the extension study. Participants were allowed to have the End of Study Visit in the lead in study combined with the Week 0 Visit for the extension study. At the Week 12 visit, participants were assigned to treatment based on 90% improvement in Psoriasis Area and Severity Index (PASI90) Score: participants with ≥PASI90 Score at Week 12 continued to receive risankizumab 90 mg by subcutaneous (SC) injection; participants with \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab 90 mg | Experimental | Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved ≥90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 continued to receive open-label (OL) risankizumab 90 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. |
|
| Risankizumab 180 mg | Experimental | Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved <90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 switched to open-label (OL) risankizumab 180 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Risankizumab administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details. | From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study) |
| Number of Participants With Drug-related TEAEs | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details. | From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period | The 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 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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study. |
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Inclusion criteria:
Participants with moderate to severe chronic plaque psoriasis, who have successfully completed Study 1311.2 (NCT02054481; the lead-in study). Successful completion of the lead-in study is defined as either of the following:
Participant must give informed consent and sign an approved consent form prior to any study procedures in accordance with Good Clinical Practice (GCP) and local legislation
Applicable only for female participants:
Negative urine pregnancy dip stick test at the roll-over visit, and if available at roll-over visit, negative Serum ß-Human Chorionic Gonadotropin (ß-HCG) test.
In addition:
Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of the roll-over visit until 12 weeks after last treatment in this study. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and intra-uterine-device.
OR
Female participants which have vasectomized sexual partner(s) (vasectomy at least 1 year prior to enrollment).
OR
Surgically sterilized female participants with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy.
OR
Postmenopausal women with postmenopausal is defined as permanent cessation ≥ 1 year of previously occurring menses.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512666 | Derived | Papp KA, de Vente S, Zeng J, Flack M, Padilla B, Tyring SK. Long-Term Safety and Efficacy of Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from a Phase 2 Open-Label Extension Trial. Dermatol Ther (Heidelb). 2021 Apr;11(2):487-497. doi: 10.1007/s13555-021-00490-3. Epub 2021 Jan 29. |
| 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 and 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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants completing lead-in study and met eligibility for this study were enrolled; demographic/disposition were not collected by dose level. Some participants in extension study had dose escalation due to lack of efficacy, predefined selected safety analysis were broken down by groups: participants remaining at 90mg and those receiving 180mg.
Analyses were performed using the intent-to-treat (ITT) population defined as all participants who received at least 1 dose of study drug. As predefined, the demographics, disposition and safety results were summarized for ITT population. Efficacy results were summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).
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| ID | Title | Description |
|---|---|---|
| FG000 | Risankizumab 90 mg or 180 mg | Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent to Treat (ITT) Population: All participants that received at least one dose of study drug in the extension study who either remained at 90 mg throughout the study or who received 180 mg were summarized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Risankizumab 90 mg or 180 mg | Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details. | Safety population, which is the same as the Intent to Treat (ITT) population for this study (defined as all participants who received at least one dose of study drug in the study), summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg | Posted | Number | participants | From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study) |
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
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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 | Risankizumab 90 mg | Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA version 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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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 | Jan 30, 2018 | May 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2018 | May 9, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details. | From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study) |
| Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period | 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. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 48 |
| Week 48 |
| Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period | 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. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 48 |
| Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period | 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. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 48 |
| Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period | 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. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Baseline, Week 48 |
| Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period | The 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 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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study. | Week 48 |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
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|
|
| Primary | Number of Participants With Drug-related TEAEs | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details. | Safety Population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg | Posted | Number | participants | From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study) |
|
|
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| Primary | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details. | Safety population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg | Posted | Number | participants | From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study) |
|
|
|
| Primary | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period | 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. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population: defined as all participants who received at least one dose of study drug in the study and summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481). | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 48 |
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| Secondary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period | The 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 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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study. | ITT Population summarized by the 4 treatment groups from the lead-in study | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
|
|
|
| Secondary | Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period | 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. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population summarized by the 4 treatment groups from the lead-in study | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 48 |
|
|
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| Secondary | Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period | 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. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population summarized by the 4 treatment groups from the lead-in study | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 48 |
|
|
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| Secondary | Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period | 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. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | ITT population summarized by the 4 treatment groups from the lead-in study | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 48 |
|
|
|
| Secondary | Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period | The 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 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. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study. | ITT Population summarized by the 4 treatment groups from the lead-in study | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
|
|
|
| 0 |
| 87 |
| 12 |
| 87 |
| 46 |
| 87 |
| EG001 | Risankizumab 180 mg | Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. | 0 | 23 | 2 | 23 | 15 | 23 |
| Goitre | Endocrine disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | Systematic Assessment |
|
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Ulnar neuritis | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 21.0 | 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.