Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

Incyte

Status and phase: Enrolling; Phase 2

Conditions: Angioedema; Hives; Chronic Spontaneous Urticaria; Urticaria; Pruritis; Chronic Idiopathic Urticaria

Treatments: Drug: Placebo; Drug: Povorcitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05936567

INCB54707-207

Details and patient eligibility

About

This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

• CSU diagnosis for ≥ 3 months prior to screening.
• CSU refractory to second-generation H1 antihistamines
• Participants must have been on a stable dose of second-generation H1 antihistamine, and must agree to maintain the stable dose of second-generation H1 antihistamine throughout study.
• Willingness and ability to comply with the study Protocol and procedures.
• Further inclusion criteria apply

Exclusion criteria

• Treatment with an anti-IgE biologic (eg, omalizumab) within 8 weeks prior to screening.
• Clearly defined underlying etiology for chronic urticarias other than CSU
• Other cutaneous or systemic diseases with chronic itching or with symptoms of urticaria or angioedema.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Concurrent or history of Thrombocytopenia, coagulopathy, or platelet dysfunction, Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, MI, coronary stenting, or CABG surgery, other significant cardiovascular diseases or uncontrolled hypertension
• Recipient of an organ transplant that requires continued immunosuppression.
• Any malignancies or history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
• Chronic or recurrent infectious disease.
• Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 4 patient groups

Povorcitinib Dose A

Experimental group

Description:

Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.

Treatment:

Drug: Povorcitinib

Povorcitinib Dose B

Experimental group

Description:

Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.

Treatment:

Drug: Povorcitinib

Povorcitinib Dose C

Experimental group

Description:

Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.

Treatment:

Drug: Povorcitinib

Placebo followed by Povorcitinib Dose A, B, or C

Experimental group

Description:

Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.

Treatment:

Drug: Povorcitinib

Drug: Placebo