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NCT Number: NCT04780516

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duplicate_Kaplan Medical Center /ID# 226569, Rehovot, Central District, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: Week 52

    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.

Secondary outcomes

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

    Time frame: Up to approximately 104 weeks

    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.

  2. Change From Baseline in Average Nightly Nocturnal Scratch Activity

    Time frame: Baseline (Week 0) to Week 52

    Average nightly nocturnal scratch activity (number of scratch events, total scratch time, and scratch intensity) will be measured by a digital monitoring device.

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

    Time frame: Up to approximately 104 weeks

    Disease duration and disease severity will be assessed by sPGA.

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

    Time frame: Up to approximately 4 weeks

    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".

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

    Time frame: Up to approximately 4 weeks

    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.

  6. Change From Baseline in Psoriasis Symptoms Scale (PSS)

    Time frame: Up to approximately 104 weeks

    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.

  7. Change From Baseline in Dermatology Life Quality Index (DLQI)

    Time frame: Up to approximately 104 weeks

    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.

  8. Change From Baseline in Work Productivity and Activity Impairment (WPAI)

    Time frame: Up to approximately 104 weeks

    WPAI measures the effect of general health and symptom severity on work productivity and regular activities during the past 7 days.

  9. Percentage of Participants With Change From Baseline DLQI > Minimal Clinically Important Difference (MCID)

    Time frame: Up to approximately 104 weeks

    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.

  10. Percentage of Participants With Durability of Response Among sPGA Responders ar Week 24

    Time frame: Up to approximately 104 weeks

    Durability of response is measured by the maintenance of the sPGA 0/1 at weeks 52 and 104.

  11. Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 104 weeks

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: prIMMa

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 3, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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