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Completed

NCT Number: NCT05936567

Study Evaluating the Efficacy and Safety of Povorcitinib in Adults 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.

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Key information

Conditions

Urticaria Angioedema Cardiovascular Diseases Chronic Disease Chronic Idiopathic Urticaria Chronic Spontaneous Urticaria Chronic Urticaria Disease Attributes Hives Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritis Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

oral; tablet

Placebo

Drug

oral; tablet

Primary outcomes

  1. Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12

    Time frame: Baseline; Week 12

    The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.

Secondary outcomes

  1. Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12

    Time frame: Week 12

    The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.

  2. Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period

    Time frame: up to Week 12

    The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.

  3. Percentage of Participants With UAS7 = 0 at Week 12

    Time frame: Week 12

    The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.

  4. Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    Time frame: up to Week 12

    An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 60 days after the last dose of study drug.

  5. Extension Period: Number of Participants With Any TEAE

    Time frame: from Week 12 to Week 44

    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 60 days after the last dose of study drug.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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