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

NCT04780516 | Active Not Recruiting

• 1 other identifier: P20-439
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 11

Brief Summary

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).

Conditions

Psoriasis

Keywords

Psoriasis; Risankizumab; Skyrizi; prIMMa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1

  Up to approximately 104 weeks

• Change From Baseline in Average Nightly Nocturnal Scratch Activity

  Baseline (Week 0) to Week 52

• Percentage of Participants With Physician Assessment Static Psoriasis Global Assessment (sPGA) 0 or 1

  Up to approximately 104 weeks

• Change From Baseline in Average Pruritus Numeric Rating Scale (PNRS)

  Up to approximately 4 weeks

• Change From Baseline in Medical Outcome Study Sleep Scale (MOS-SS)

  Up to approximately 4 weeks

Study Arms (1)

Participants Treated With Risankizumab

Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderate to severe psoriasis who are prescribed risankizumab according to local label prior to enrolling in this study.

You may qualify if:

• 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.

You may not qualify if:

• Participants participating in a concurrent clinical interventional study or within 30 days.
• Participants treated with risankizumab prior to baseline visit.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (11)

Duplicate_Kaplan Medical Center /ID# 226569

Rehovot, Central District, 7661041, Israel

Location

Leumit /ID# 252029

Rehovot, Central District, 9458414, Israel

Location

HaEmek Medical Center /ID# 251040

Afula, Haifa District, 1834111, Israel

Location

Shaare Zedek Medical Center /ID# 247319

Jerusalem, Jerusalem, 91031, Israel

Location

ZIV Medical Center /ID# 226565

Safed, Northern District, 13100, Israel

Location

Barzilai Medical Center /ID# 229156

Ashkelon, Southern District, 7830604, Israel

Location

Soroka University Medical Center /ID# 226570

Beersheba, Southern District, 8410101, Israel

Location

The Chaim Sheba Medical Center /ID# 226562

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 226564

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Maccabi /ID# 246679

Haifa, 7176250, Israel

Location

Rabin Medical Center /ID# 226568

Petah Tikva, 4941492, Israel

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: April 26, 2021
• Primary Completion: January 2, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IL (11)