Actively Recruiting
Upadacitinib Treatment for Moderate-to-Severe Prurigo Nodularis A 24-Week Open-Label Study Evaluating Efficacy and Safety
Led by Psoriasis Treatment Center of Central New Jersey · Updated on 2025-01-15
25
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
P
Psoriasis Treatment Center of Central New Jersey
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating upadacitinib in adults aged 18 to 64 with moderate-to-severe prurigo nodularis, a chronic skin condition characterized by itchy nodules. This phase 4, open-label study aims to assess the effectiveness and safety of upadacitinib over 24 weeks in patients who have not adequately responded to topical corticosteroids or for whom such treatments are not suitable. All participants will start treatment with 15 mg of upadacitinib. At week 8, the dose may be increased to 30 mg if deemed necessary by the investigators. The study focuses on monitoring participants throughout 24 weeks of treatment to observe changes in itch severity and other symptoms. Participants will undergo assessments including evaluation of their prurigo nodularis lesions, safety monitoring, and measurements of itch severity using a numeric rating scale at week 12. Researchers will also monitor overall health through medical history, physical exams, and pregnancy tests when applicable. The study involves regular follow-up visits and safety checks to evaluate treatment response and adverse effects.
CONDITIONS
Official Title
Upadacitinib for Prurigo Nodularis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 to 64 years at screening
- Diagnosis of prurigo nodularis for 3 months or longer
- Moderate-to-severe prurigo nodularis with at least 10 lesions on legs, arms, or trunk
- Failure of a 2-week course of medium to super potent topical corticosteroids or corticosteroids not medically advisable
- Females of childbearing potential must have negative pregnancy tests and use effective birth control during and 30 days after the study
- Candidate for systemic therapy as determined by the investigator
- Able and willing to provide written informed consent
- In general good health based on medical history and physical exam
You will not qualify if you...
- Presence of skin conditions other than prurigo nodularis or atopic dermatitis interfering with assessments
- Diagnosis of active atopic dermatitis at screening and baseline
- Prurigo nodularis caused by medications or medical conditions such as neuropathy or psychiatric disease
- Severe uncontrolled illnesses that could affect study participation
- Severe kidney conditions such as uremia or dialysis
- Uncontrolled thyroid disease
- Active or incompletely treated tuberculosis or other mycobacterial infections without adequate treatment
- Active or suspected endoparasitic infections unless ruled out before enrollment
- Active infections requiring systemic treatment within 2 weeks before screening
- Known or suspected immunodeficiency
- Active cancer or history of malignancy within 5 years except certain resolved skin or cervical cancers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eczema Treatment Center of New Jersey
East Windsor, New Jersey, United States, 08520
Actively Recruiting
Research Team
A
Ashley Reed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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