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Janus Kinase (JAK) Inhibitor
Abrocitinib for Skin Diseases
Phase 2
Waitlist Available
Led By Shawn G Kwatra, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males or female participants between ages 18-80 years at time of signing informed consent
A clinical diagnosis of prurigo nodularis, defined by the presence of at least 10 pruritic nodules on at least 2 different anatomic locations (with each arm, leg, and anterior and posterior trunk considered distinct anatomic locations)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study Summary
This study is evaluating whether a drug called Abrocitinib can help people with prurigo nodularis.
Eligible Conditions
- Skin Diseases
- Itching
- Prurigo Nodularis
- Chronic Pruritus
- Chronic Prurigo
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12
Secondary outcome measures
Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
+13 moreSide effects data
From 2022 Phase 2 trial • 20 Patients • NCT0503898210%
Sore throat
10%
Acneiform Eruption
10%
Nasal Congestion
10%
Nausea
10%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prurigo Nodularis
Chronic Pruritus of Unknown Origin
Trial Design
2Treatment groups
Experimental Treatment
Group I: Prurigo NodularisExperimental Treatment1 Intervention
Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants).
Group II: Chronic Pruritus of Unknown OriginExperimental Treatment1 Intervention
Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abrocitinib
2021
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,245 Previous Clinical Trials
14,816,086 Total Patients Enrolled
4 Trials studying Skin Diseases
572 Patients Enrolled for Skin Diseases
Duke UniversityOTHER
2,351 Previous Clinical Trials
3,407,814 Total Patients Enrolled
PfizerIndustry Sponsor
4,559 Previous Clinical Trials
10,907,840 Total Patients Enrolled
7 Trials studying Skin Diseases
3,766 Patients Enrolled for Skin Diseases
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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