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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 (prIMMa)

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ClinicalTrials.gov Identifier: NCT04780516
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).


Condition or disease
Psoriasis

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 14, 2024
Estimated Study Completion Date : August 14, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
Participants Treated With Risankizumab
Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780516


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04780516    
Other Study ID Numbers: P20-439
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Psoriasis
Risankizumab
Skyrizi
prIMMa
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases