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

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05936567
• Collaborator: (none)
• Enrollment: 136
• Arms: 4
• Anticipated Duration (Months): 25.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urticaria; Chronic Spontaneous Urticaria; Chronic Idiopathic Urticaria; Hives; Angioedema; Pruritis	Drug: Povorcitinib; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
• Anticipated Study Start Date: Jul 10, 2023
• Anticipated Primary Completion Date: Mar 7, 2025
• Anticipated Study Completion Date: Sep 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Povorcitinib Dose A Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.	Drug: Povorcitinib; oral; tablet
Experimental: Povorcitinib Dose B Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.	Drug: Povorcitinib; oral; tablet
Experimental: Povorcitinib Dose C Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.	Drug: Povorcitinib; oral; tablet
Experimental: Placebo followed by Povorcitinib Dose A, B, or C 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.	Drug: Povorcitinib; oral; tablet; Drug: Placebo; oral; tablet

Outcome Measures

Primary Outcome Measures

1. Change from baseline in the urticaria activity score (UAS7) [12 Weeks]

   Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity.

Secondary Outcome Measures

1. Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12 [12 Weeks]

   Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity.

2. Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period [12 Weeks]

   Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS. UAS scores range from 0-42; with higher scores reflecting greater disease activity.

3. Proportion of participants with UAS7 = 0 at Week 12. [12 Weeks]

   Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Incyte Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT05936567
• Other Study ID Numbers: INCB54707-207
• First Posted: Jul 7, 2023
• Last Update Posted: Jul 7, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Angioedema; Urticaria; Chronic Urticaria

Study Results

No Results Posted as of Jul 7, 2023