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Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis.
Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel.
Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years.
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, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Treated With Risankizumab | Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1 | DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1 | DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. | Up to approximately 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with moderate to severe psoriasis who are prescribed risankizumab according to local label prior to enrolling in this study.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duplicate_Kaplan Medical Center /ID# 226569 | Rehovot | Central District | 7661041 | Israel | ||
| Leumit /ID# 252029 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41915361 | Derived | Snast I, Valdman-Grinshpoun Y, Bathish N, Matz H, Shclar Y, Murad S, Czarnowicki T, Shavit E, Yang L, Goss S, Maor IP, Halperin A, Blonder SN, Cohen R, Bleterman A, Barak M, Pavlovsky L. Effectiveness, Quality of Life and Durability of Risankizumab in Patients with Moderate-to-Severe Psoriasis: Real-World Evidence from the PRIMMA Study. Dermatol Ther (Heidelb). 2026 May;16(5):2525-2540. doi: 10.1007/s13555-026-01729-7. Epub 2026 Mar 31. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Change From Baseline in Average Nightly Nocturnal Scratch Activity |
Average nightly nocturnal scratch activity (number of scratch events, total scratch time, and scratch intensity) will be measured by a digital monitoring device. |
| Baseline (Week 0) to Week 52 |
| Percentage of Participants With Physician Assessment Static Psoriasis Global Assessment (sPGA) 0 or 1 | Disease duration and disease severity will be assessed by sPGA. | Up to approximately 104 weeks |
| Change From Baseline in Average Pruritus Numeric Rating Scale (PNRS) | PNRS is a patient reported score that assesses itch severity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst imaginable itch". | Up to approximately 4 weeks |
| Change From Baseline in Medical Outcome Study Sleep Scale (MOS-SS) | Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache over the past 4 weeks. | Up to approximately 4 weeks |
| Change From Baseline in Psoriasis Symptoms Scale (PSS) | PSS is a 4-item scale designed to measure patient-reported psoriasis symptoms. The PSS consists of four items assessing severity of pain, itching, redness, and burning during the past 24 h. A 5-point severity scale was used as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. | Up to approximately 104 weeks |
| Change From Baseline in Dermatology Life Quality Index (DLQI) | DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. | Up to approximately 104 weeks |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI) | WPAI measures the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. | Up to approximately 104 weeks |
| Percentage of Participants With Change From Baseline DLQI > Minimal Clinically Important Difference (MCID) | DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The MCID is defined as an improvement of >= 5 points in DLQI. | Up to approximately 104 weeks |
| Percentage of Participants With Durability of Response Among sPGA Responders ar Week 24 | Durability of response is measured by the maintenance of the sPGA 0/1 at weeks 52 and 104. | Up to approximately 104 weeks |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. 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. | Up to approximately 104 weeks |
| Rehovot |
| Central District |
| 9458414 |
| Israel |
| HaEmek Medical Center /ID# 251040 | Afula | Haifa District | 1834111 | Israel |
| Shaare Zedek Medical Center /ID# 247319 | Jerusalem | Jerusalem | 91031 | Israel |
| ZIV Medical Center /ID# 226565 | Safed | Northern District | 13100 | Israel |
| Barzilai Medical Center /ID# 229156 | Ashkelon | Southern District | 7830604 | Israel |
| Soroka University Medical Center /ID# 226570 | Beersheba | Southern District | 8410101 | Israel |
| The Chaim Sheba Medical Center /ID# 226562 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 226564 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Maccabi /ID# 246679 | Haifa | 7176250 | Israel |
| Rabin Medical Center /ID# 226568 | Petah Tikva | 4941492 | Israel |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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