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 Clinical Trial

— prIMMa  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780516
• Other study ID #: P20-439
• Status: Completed
• Start date: April 26, 2021
• Est. completion date: January 2, 2024

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Israel	HaEmek Medical Center /ID# 251040	Afula	HaDarom
Israel	Barzilai Medical Center /ID# 229156	Ashkelon	HaDarom
Israel	Soroka University Medical Center /ID# 226570	Be'er Sheva	HaDarom
Israel	Maccabi /ID# 246679	Haifa	H_efa
Israel	Rabin Medical Center /ID# 226568	Haifa	H_efa
Israel	Shaare Zedek Medical Center /ID# 247319	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 226562	Ramat Gan	Tel-Aviv
Israel	Kaplan Medical Center /ID# 226569	Rehovot	HaMerkaz
Israel	Leumit /ID# 252029	Rehovot	HaMerkaz
Israel	ZIV Medical Center /ID# 226565	Safed	HaTsafon
Israel	Tel Aviv Sourasky Medical Center /ID# 226564	Tel Aviv	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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