A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Overview

Información sobre este estudio

The [urpose of this study is to assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.  

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Diagnosis of HS for at least 6 months prior to Baseline, as determined by the
investigator (i.e., through medical history and interview of subject).

- Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks
and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks
characterized by inadequate response or for any duration characterized by intolerance
as determined by the investigator.

- Participant must have a total AN count of ≥ 5 at Baseline.

- HS lesions must be present in at least 2 distinct anatomic areas at Baseline.

- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher
at Baseline.

- Draining fistula count of ≤ 20 at Baseline.

Exclusion Criteria:

- History of active skin disease other than HS that could interfere with the assessment
of HS, including skin infections (bacterial, fungal, or viral) requiring systemic
treatment within 4 weeks of the Baseline visit.

- Treatment with any investigational drug of chemical or biologic nature within a
minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of
study drug or be currently enrolled in another interventional clinical study.
Investigational drugs are also prohibited during the study.

- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count
returns to normal level or pre-treatment level.

- Use of prescription topical therapies (including topical antibiotics) that can also be
used to treat HS within 14 days prior to the Baseline visit.

- Received any systemic (including oral) antibiotic treatment for HS or any other
chronic inflammatory disorder within 14 days prior to the Baseline visit.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/5/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Aaron Mangold, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Aaron Mangold M.D.

Mangold.Aaron@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20561680

Mayo Clinic Footer