RECRUITING

Upadacitinib for Prurigo Nodularis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.

Official Title

A 24 Week, Open-Label Study to Evaluate the Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Prurigo Nodularis

Quick Facts

Study Start:2024-04-09

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06773403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female adult 18-64 years of age at time of screening. 2. Diagnosis of prurigo nodularis for ≥ 3 months. 3. Moderate-to-Severe prurigo nodularis as determined by at least 10 PN lesions on legs and/or arms and/or trunk at screening and baseline . 4. Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject. 5. Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility. 6. Subject is a candidate for systemic therapy per investigator discretion. 7. Able and willing to give written informed consent prior to performance of any study-related procedures. 8. Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.	1. Presence of skin condition other than prurigo nodularis or atopic dermatitis that may interfere with study assessments. 2. Diagnosis of active atopic dermatitis at screening and baseline. 3. PN secondary to medications. 4. PN secondary to medical conditions such as neuropathy or psychiatric disease. 5. Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study. 6. Severe renal conditions (eg, patients with uremia and/or on dialysis) 7. Participants with uncontrolled thyroid disease. 8. Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. Patients with latent TB at screening may be enrolled if tuberculosis treatment is initiated prior to first dose. 9. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization. 10. Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period. 11. Known or suspected immunodeficiency. 12. Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

Inclusion Criteria

Exclusion Criteria

1. Male or female adult 18-64 years of age at time of screening.
2. Diagnosis of prurigo nodularis for ≥ 3 months.
3. Moderate-to-Severe prurigo nodularis as determined by at least 10 PN lesions on legs and/or arms and/or trunk at screening and baseline .
4. Failure of at least a 2-week course of medium to super potent TCS or TCS is not medically advisable for subject.
5. Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility.
6. Subject is a candidate for systemic therapy per investigator discretion.
7. Able and willing to give written informed consent prior to performance of any study-related procedures.
8. Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.

1. Presence of skin condition other than prurigo nodularis or atopic dermatitis that may interfere with study assessments.
2. Diagnosis of active atopic dermatitis at screening and baseline.
3. PN secondary to medications.
4. PN secondary to medical conditions such as neuropathy or psychiatric disease.
5. Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study.
6. Severe renal conditions (eg, patients with uremia and/or on dialysis)
7. Participants with uncontrolled thyroid disease.
8. Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. Patients with latent TB at screening may be enrolled if tuberculosis treatment is initiated prior to first dose.
9. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
10. Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
11. Known or suspected immunodeficiency.
12. Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

Contacts and Locations

Study Contact

Ashley Reed

CONTACT

609-443-4500

ashley.reed@schweigerderm.com

Study Locations (Sites)

Eczema Treatment Center of New Jersey

East Windsor, New Jersey, 08520

United States

Collaborators and Investigators

Sponsor: Psoriasis Treatment Center of Central New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-09

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-04-09

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Prurigo Nodularis