Phase 2
N=136
Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
Urticaria · Chronic Spontaneous Urticaria · Chronic Idiopathic Urticaria · Hives · Angioedema
Bottom Line
View on ClinicalTrials.gov: NCT05936567 ↗Enrolled (actual)
136
Serious AEs
1.6%
Results posted
Mar 2026
Primary outcome: Primary: Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 — -17.90; -17.25; -19.83; -23.91 scores on a scale — p=0.8298
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Povorcitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 |
-17.90; -17.25; -19.83; -23.91 | 0.8298 |
| SECONDARY Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12 |
29.4; 30.3; 44.1; 62.9 | 0.9366 |
| SECONDARY Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period |
NA; 54.0; 54.0; 20.0 | — |
| SECONDARY Percentage of Participants With UAS7 = 0 at Week 12 |
23.5; 24.2; 29.4; 42.9 | 0.9469 |
| SECONDARY Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
16; 24; 18; 23 | — |
| SECONDARY Extension Period: Number of Participants With Any TEAE |
20; 20; 23; 5; 5; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05936567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.