NCT04780516Active, not recruiting
Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care
Prospective Non-Interventional Study to Investigate the Durable Effectiveness of Risankizumab Using Digital and Remote Evaluation Tools in Moderate to Severe Psoriasis Patients - prIMMa Study
Source: ClinicalTrials.gov · Last updated 13 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 141 (actual)
- First submitted
- 1 Mar 2021
- Start date
- 26 Apr 2021
- Primary completion date
- 2 Jan 2024
- Lead sponsor
- AbbVie
- Diseases
- Psoriasis
- NCT number
- NCT04780516
What you commit to
- Study type: Observational
- Participants enrolled: 141
- From 26 Apr 2021 to the primary completion date, 2 Jan 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants participating in a concurrent clinical interventional study or within 30 days.
- Participants treated with risankizumab prior to baseline visit.
Who the study is looking for
- Clinical diagnosis of moderate to severe psoriasis.
- Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.
- Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.
- Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score \>=4 at baseline.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HaEmek Medical Center /ID# 251040 Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Barzilai Medical Center /ID# 229156 Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Soroka University Medical Center /ID# 226570 Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Maccabi /ID# 246679 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center /ID# 247319 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center /ID# 226568 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 226562 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Leumit /ID# 252029 Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Duplicate_Kaplan Medical Center /ID# 226569 Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| ZIV Medical Center /ID# 226565 Coordinator of this site? Confirm its status | Safed | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 226564 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
Related publications
- 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 · PMID 41915361
This page is information, not medical advice. Discuss any trial with your doctor.