TERMINATED

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

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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 prospective, single-arm, open-label trial of deucravacitinib 6 mg daily in patients with PPP. All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.

Official Title

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Quick Facts

Study Start:2023-07-01

Study Completion:2025-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05710185

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* • Adults aged 18 years of age and older * Dermatologist confirmed diagnosis of PPP for at least 6 months * Moderate-severe PPP, defined as a ppPASI \> 12 * Inadequate response to topical therapy and a candidate for systemic or phototherapy * Willing to discontinue current topical and/or systemic PPP treatments, except for OTC emollients	* • Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments * Current/recent administration of PPP-specific medications including: * Rituximab within 6 months of the baseline visit * Biologics within 12 weeks of baseline visit * Systemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visit * Phototherapy within 4 weeks of baseline visit * Prescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visit * History of active infection and/or febrile illness within 7 days; or infection requiring antibiotic treatment within 30 days; or serious infection requiring hospitalization and/or IV antibiotics within 90 days * Evidence of other infection including: * Active or untreated latent tuberculosis, defined as radiographic or laboratory evidence of active TB or positive quantiferon or PPD, unless the subject has completed the recommended treatment * Human immunodeficiency virus infection (positive HIV antibody) * Active hepatitis B * Active hepatitis C * Evidence of clinically significant laboratory abnormality including: * Absolute WBC count \< 3000/mm3 * Platelet count \< 100,000/mm3 * Hemoglobin \< 9.0 g/dl * ALT or AST \> 3 times the upper limit of normal * History of cancer within the past 5 years, excluding treated non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) * Other uncontrolled chronic medical condition that may interfere with a patient's ability to participate in the clinical trial * Major surgery within 4 weeks of baseline visit * Receipt of live vaccine within 8 weeks of baseline visit * Pregnant or breastfeeding individuals * Inability to comply with any of the study procedures * Individuals who are incarcerated or compulsory detained

Inclusion Criteria

Exclusion Criteria

* • Adults aged 18 years of age and older
* Dermatologist confirmed diagnosis of PPP for at least 6 months
* Moderate-severe PPP, defined as a ppPASI \> 12
* Inadequate response to topical therapy and a candidate for systemic or phototherapy
* Willing to discontinue current topical and/or systemic PPP treatments, except for OTC emollients

* • Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments
* Current/recent administration of PPP-specific medications including:
* Rituximab within 6 months of the baseline visit
* Biologics within 12 weeks of baseline visit
* Systemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visit
* Phototherapy within 4 weeks of baseline visit
* Prescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visit
* History of active infection and/or febrile illness within 7 days; or infection requiring antibiotic treatment within 30 days; or serious infection requiring hospitalization and/or IV antibiotics within 90 days
* Evidence of other infection including:
* Active or untreated latent tuberculosis, defined as radiographic or laboratory evidence of active TB or positive quantiferon or PPD, unless the subject has completed the recommended treatment
* Human immunodeficiency virus infection (positive HIV antibody)
* Active hepatitis B
* Active hepatitis C
* Evidence of clinically significant laboratory abnormality including:
* Absolute WBC count \< 3000/mm3
* Platelet count \< 100,000/mm3
* Hemoglobin \< 9.0 g/dl
* ALT or AST \> 3 times the upper limit of normal
* History of cancer within the past 5 years, excluding treated non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)
* Other uncontrolled chronic medical condition that may interfere with a patient's ability to participate in the clinical trial
* Major surgery within 4 weeks of baseline visit
* Receipt of live vaccine within 8 weeks of baseline visit
* Pregnant or breastfeeding individuals
* Inability to comply with any of the study procedures
* Individuals who are incarcerated or compulsory detained

Contacts and Locations

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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 Date2023-07-01

Study Completion Date2025-01-31

Study Record Updates

Study Start Date2023-07-01

Study Completion Date2025-01-31

Terms related to this study

Additional Relevant MeSH Terms

Palmoplantar Pustulosis