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

April 9, 2024 updated by: Incyte Corporation

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Not yet recruiting
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitatsklinikum Frankfurt
      • Hamburg, Germany, 22391
        • Recruiting
        • MENSINGDERMA research GmbH
      • Kiel, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig AöR
      • Mainz, Germany, 55131
        • Recruiting
        • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
      • Osnabrück, Germany, 49074
        • Recruiting
        • Klifos - Klinische Forschung Osnabruck
      • Tuebingen, Germany, 72076
        • Recruiting
        • Universitats-Hautklink Tubingen
  • Poland
      • Bialystok, Poland, 15-375
        • Recruiting
        • Specderm Poznanska
      • Katowice, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia Katowice I
      • Lublin, Poland, 20-552
        • Recruiting
        • Centrum Alergologii Sp Z.O.O
      • Opole, Poland, 45-401
        • Not yet recruiting
        • University Clinical Hospital
      • Poznan, Poland, 60-529
        • Recruiting
        • Solumed Centrum Medyczne
      • Poznan, Poland, 60-693
        • Recruiting
        • Specjalistyczny Nzoz Alergologia Plus
      • Swidnica, Poland, 58-100
        • Recruiting
        • Dc-Med
      • Warszawa, Poland, 02-793
        • Recruiting
        • Etg Warszawa
      • Warszawa, Poland, 02-507
        • Not yet recruiting
        • Centralny Szpital Kliniczny Mswia
      • Warszawa, Poland, 02-953
        • Recruiting
        • Klinika Ambroziak
      • Wroclaw, Poland, 50-449
        • Recruiting
        • Melita Medical Sp. Z O. O.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Clinical Research Center of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Foothills Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Little Rock Allergy Asthma, Pa Clinical Research Center Lraac
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Arkansas Research Trials
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First OC Dermatology
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Newport Native Md
      • Palmdale, California, United States, 93551
        • Recruiting
        • Antelope Valley Allergy Medical Group
      • Redwood City, California, United States, 94063
        • Recruiting
        • Allergy and Asthma Consultants, Pc
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Treasure Valley Medical Research
    • Illinois
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Midwest Allergy Sinus Asthma, SC
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • David Fivenson, MD, Dermatology, PLLC
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute, Llc Troy
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • The Clinical Research Center Crc, Llc
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • Optimed Research Ltd
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Vital Prospects Clinical Research Institute, Pc Vpcri
    • Pennsylvania
      • Sugarloaf, Pennsylvania, United States, 18249
        • Recruiting
        • Dermdox Center For Dermatology
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • Allergy and Asthma Center of Charleston
    • Texas
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Rainey and Finklea Dermatology
    • Washington
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • Bellingham Asthma, Allergy Immunology Clinic

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the urticaria activity score (UAS7)
Time Frame: 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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12
Time Frame: 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.
12 Weeks
Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period
Time Frame: 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.
12 Weeks
Proportion of participants with UAS7 = 0 at Week 12.
Time Frame: 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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

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 Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

March 7, 2025

Study Completion (Estimated)

September 5, 2025

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB54707-207

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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