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

Primary Purpose

Urticaria, Chronic Spontaneous Urticaria, Chronic Idiopathic Urticaria

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Povorcitinib
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinical Research Center of Alabama
  • Center For Dermatology and Plastic SurgeryRecruiting
  • Arkansas Research TrialsRecruiting
  • First Oc DermatologyRecruiting
  • Newport Native Md
  • Antelope Valley Allergy Medical GroupRecruiting
  • Allergy and Asthma Consultants, PcRecruiting
  • Treasure Valley Medical ResearchRecruiting
  • Midwest Allergy Sinus Asthma, ScRecruiting
  • David Fivenson, Md, Dermatology, Pllc
  • Revival Research Institute, Llc TroyRecruiting
  • The Clinical Research Center Crc, LlcRecruiting
  • Optimed Research LtdRecruiting
  • Vital Prospects Clinical Research Institute, Pc VpcriRecruiting
  • Dermdox Center For DermatologyRecruiting
  • Pharmaceutical Research and Consulting, Inc
  • Rainey and Finklea DermatologyRecruiting
  • Bellingham Asthma, Allergy Immunology ClinicRecruiting
  • Seattle Allergy Asthma Research Institute Asthma, Inc Clinical Research Center
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Universitaetsklinikum Carl Gustav Carus Tu Dresden
  • Universitatsklinikum Frankfurt
  • Mensingderma Research Gmbh
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Universitaetsklinikum Leipzig Aoer
  • Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz
  • Klifos - Klinische Forschung Osnabruck
  • Universitats-Hautklink Tubingen
  • Specderm Poznanska
  • Centrum Medyczne Pratia Katowice I
  • Centrum Alergologii Sp Z.O.O
  • University Clinical Hospital
  • Solumed Centrum Medyczne
  • Specjalistyczny Nzoz Alergologia Plus
  • DC-MED
  • Centralny Szpital Kliniczny Mswia
  • Etg Warszawa
  • Klinika Ambroziak Estederm
  • Melita Medical Sp. Z O. O.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Povorcitinib Dose A

Povorcitinib Dose B

Povorcitinib Dose C

Placebo followed by Povorcitinib Dose A, B, or C

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

Change from baseline in the urticaria activity score (UAS7)
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

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

Full Information

First Posted
June 26, 2023
Last Updated
October 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05936567
Brief Title
Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
Official Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
March 7, 2025 (Anticipated)
Study Completion Date
September 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria, Chronic Spontaneous Urticaria, Chronic Idiopathic Urticaria, Hives, Angioedema, Pruritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Povorcitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
Arm Title
Povorcitinib Dose B
Arm Type
Experimental
Arm Description
Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
Arm Title
Povorcitinib Dose C
Arm Type
Experimental
Arm Description
Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Arm Title
Placebo followed by Povorcitinib Dose A, B, or C
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Povorcitinib
Intervention Description
oral; tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral; tablet
Primary Outcome Measure Information:
Title
Change from baseline in the urticaria activity score (UAS7)
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12
Description
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.
Time Frame
12 Weeks
Title
Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period
Description
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.
Time Frame
12 Weeks
Title
Proportion of participants with UAS7 = 0 at Week 12.
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Center For Dermatology and Plastic Surgery
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Newport Native Md
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Antelope Valley Allergy Medical Group
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy and Asthma Consultants, Pc
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Allergy Sinus Asthma, Sc
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Recruiting
Facility Name
David Fivenson, Md, Dermatology, Pllc
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Revival Research Institute, Llc Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
The Clinical Research Center Crc, Llc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Optimed Research Ltd
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, Pc Vpcri
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermdox Center For Dermatology
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmaceutical Research and Consulting, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rainey and Finklea Dermatology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Individual Site Status
Recruiting
Facility Name
Bellingham Asthma, Allergy Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Allergy Asthma Research Institute Asthma, Inc Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus Tu Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Mensingderma Research Gmbh
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Leipzig Aoer
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klifos - Klinische Forschung Osnabruck
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitats-Hautklink Tubingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Specderm Poznanska
City
Bialystok
ZIP/Postal Code
15-375
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne Pratia Katowice I
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Alergologii Sp Z.O.O
City
Lublin
ZIP/Postal Code
20-552
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
University Clinical Hospital
City
Opole
ZIP/Postal Code
46-020
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Specjalistyczny Nzoz Alergologia Plus
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
DC-MED
City
Swidnica
ZIP/Postal Code
58-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centralny Szpital Kliniczny Mswia
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Etg Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Klinika Ambroziak Estederm
City
Warszawa
ZIP/Postal Code
02-953
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Melita Medical Sp. Z O. O.
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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