Selective treatment with oral Povorcitinib in prurigo nodularis (PN)

Zusammenfassung der Studie

Summary This is a multicenter, randomized, double-blind, placebo-controlled (PC) phase III study to evaluate the efficacy and safety of Povorcitinib over a PC period of 24 weeks, followed by a 24-week extension period (EXT). Before the first dose of the investigational product, participants will be examined for up to 28 days. It is assumed that participants will be in the study for approximately 13 months. In the study, approximately 330 participants worldwide and about 10 participants in Switzerland will be assigned during the 24-week PC period to one of three treatment groups: • Povorcitinib Dose A once daily • Povorcitinib Dose B once daily • Placebo once daily At the end of the 24-week PC period, participants will begin the 24-week EXT period. Participants who were originally randomized to placebo will be equally assigned to one of these two doses of Povorcitinib. Participants will receive the investigational product until the end of the 48-week treatment period or until one of the criteria for discontinuation of study treatment is met. Participants who complete the PC and EXT periods may be eligible to participate in an extension study. Participants who do not continue in the extension study will return for a safety follow-up approximately 30 days after their last dose of the investigational product.

(BASEC)

Untersuchte Intervention

Participants will be randomized (1:1:1) and will receive during the 24-week PC period Povorcitinib Dose A once daily, Povorcitinib Dose B once daily, or a corresponding placebo. At the end of the 24-week PC period, participants will begin the 24-week EXT period. During the EXT period, participants who were originally randomized to Povorcitinib Dose A once daily or Dose B once daily will continue to receive Povorcitinib at the same dose, and participants who were originally randomized to placebo will be equally assigned to one of these two doses of Povorcitinib.

(BASEC)

Untersuchte Krankheit(en)

Prurigo nodularis (PN) is a neuroinflammatory, fibrotic dermatosis (excessive scarring of the skin) characterized by chronic pruritus (itching lasting more than 6 weeks), scratch-related itchy skin lesions, and a history of repeated scratching. The intensely itchy nodules are symmetrically distributed and most commonly occur on the outer sides of the arms and legs as well as on the trunk. The upper back, abdomen, and coccyx may also be affected; however, the hard-to-reach upper mid-back area is usually spared. Prurigo nodularis skin lesions appear as firm, dome-shaped, itchy nodules (also referred to as lesions) that range in size from a few millimeters to several centimeters. In addition to itching, patients may experience burning, tingling, and pain. The exact pathogenesis of PN remains unknown; however, there is evidence of significant interaction and abnormal regulation between immune cells and nerve fibers, leading to a skin reaction pattern that causes endless cycles of chronic itching followed by repeated scratching. Itching usually precedes the nodules. In a subset of patients with chronic itching, PN occurs as a result of constant scratching. Prurigo nodularis has significant negative impacts on quality of life and is associated with sleep disturbances, impaired work performance, and avoidance of social activities. The burden of comorbidities (cardiovascular, pulmonary, and other systemic diseases) in prurigo nodularis often exceeds that of other inflammatory skin diseases (e.g., atopic dermatitis or psoriasis).

(BASEC)

Sponsor

Sponsor: Incyte Corporation, USA Sponsor’s representative in Switzerland: ICON Clinical Research (Switzerland) GmbH

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

20.12.2024

(BASEC)

Ergebnisse der Studie