A Phase 2 interventional study of Povorcitinib and Placebo in Urticaria, Chronic Spontaneous Urticaria and Chronic Idiopathic Urticaria, sponsored by Incyte Corporation. Completed at 42 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
147 studies on the registry are indexed under Urticaria; 19 are open to participants now.
This study's enrollment of 136 is above the median of 51 across 104 interventional studies indexed under Urticaria.
Browse Urticaria studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
Drug: Povorcitinib
Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
Drug: Povorcitinib
Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Drug: Povorcitinib
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 · Drug: Placebo
oral; tablet
oral; tablet
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at 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.
Time frame: Baseline; Week 12
Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at 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.
Time frame: Week 12
Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period
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.
Time frame: up to Week 12
Percentage of Participants With UAS7 = 0 at 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.
Time frame: Week 12
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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.
Time frame: up to Week 12
Extension Period: Number of Participants With Any TEAE
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.
Time frame: from Week 12 to Week 44
| Milestone | Placebo | Povorcitinib 15 mg QD to 15 mg QD | Povorcitinib 45 mg QD to 45 mg QD | Povorcitinib 75 mg QD to 75 mg QD | Placebo to Povorcitinib 15 mg | Placebo to Povorcitinib 45 mg | Placebo to Povorcitinib 75 mg |
|---|---|---|---|---|---|---|---|
| Started | 34 | 33 | 34 | 35 | 0 | 0 | 0 |
| Completed | 26 | 29 | 30 | 32 | 0 | 0 | 0 |
| Not completed | 8 | 4 | 4 | 3 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 5 | 2 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Noncompliance with study treatment | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Sponsor decision to terminate patient | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | Povorcitinib 15 mg QD to 15 mg QD | Povorcitinib 45 mg QD to 45 mg QD | Povorcitinib 75 mg QD to 75 mg QD | Placebo to Povorcitinib 15 mg | Placebo to Povorcitinib 45 mg | Placebo to Povorcitinib 75 mg |
|---|---|---|---|---|---|---|---|
| Started | 0 | 29 | 30 | 32 | 9 | 7 | 10 |
| Completed | 0 | 26 | 24 | 26 | 7 | 7 | 8 |
| Not completed | 0 | 3 | 6 | 6 | 2 | 0 | 2 |
| Withdrew: Adverse event | 0 | 0 | 2 | 1 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 3 | 4 | 1 | 0 | 0 |
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.
| scores on a scale | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD |
|---|---|---|---|---|
| Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 | -17.90 ± 2.21 | -17.25 ± 2.09 | -19.83 ± 2.08 | -23.91 ± 2.01 |
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.
| percentage of participants | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD |
|---|---|---|---|---|
| Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12 | 29.4 (15.1 to 47.5) | 30.3 (15.6 to 48.7) | 44.1 (27.2 to 62.1) | 62.9 (44.9 to 78.5) |
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.
| days | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD |
|---|---|---|---|---|
| Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period | NA (37.0 to NA) | 54.0 (28.0 to NA) | 54.0 (27.0 to NA) | 20.0 (12.0 to 27.0) |
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.
| percentage of participants | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD |
|---|---|---|---|---|
| Percentage of Participants With UAS7 = 0 at Week 12 | 23.5 (10.7 to 41.2) | 24.2 (11.1 to 42.3) | 29.4 (15.1 to 47.5) | 42.9 (26.3 to 60.6) |
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.
| Participants | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD |
|---|---|---|---|---|
| Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 16 | 24 | 18 | 23 |
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.
| Participants | Povorcitinib 15 mg QD to 15 mg QD | Povorcitinib 45 mg QD to 45 mg QD | Povorcitinib 75 mg QD to 75 mg QD | Placebo to Povorcitinib 15 mg | Placebo to Povorcitinib 45 mg | Placebo to Povorcitinib 75 mg |
|---|---|---|---|---|---|---|
| Extension Period: Number of Participants With Any TEAE | 20 | 20 | 23 | 5 | 5 | 4 |
Collected over up to Week 44. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/34 (0%) | 3/34 (8.8%) | 8/34 (23.5%) |
| Povorcitinib 15 mg QD | 0/33 (0%) | 0/33 (0%) | 10/33 (30.3%) |
| Povorcitinib 45 mg QD | 0/34 (0%) | 0/34 (0%) | 12/34 (35.3%) |
| Povorcitinib 75 mg QD | 1/35 (2.9%) | 0/35 (0%) | 17/35 (48.6%) |
| Placebo to Povorcitinib 15 mg | 0/9 (0%) | 0/9 (0%) | 5/9 (55.6%) |
| Placebo to Povorcitinib 45 mg | 0/7 (0%) | 0/7 (0%) | 5/7 (71.4%) |
| Placebo to Povorcitinib 75 mg | 0/10 (0%) | 0/10 (0%) | 4/10 (40%) |
| Povorcitinib 15 mg QD to 15 mg QD | 0/29 (0%) | 0/29 (0%) | 14/29 (48.3%) |
| Povorcitinib 45 mg QD to 45 mg QD | 0/30 (0%) | 0/30 (0%) | 16/30 (53.3%) |
| Povorcitinib 75 mg QD to 75 mg QD | 1/32 (3.1%) | 1/32 (3.1%) | 17/32 (53.1%) |
| Event | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD | Placebo to Povorcitinib 15 mg | Placebo to Povorcitinib 45 mg | Placebo to Povorcitinib 75 mg | Povorcitinib 15 mg QD to 15 mg QD | Povorcitinib 45 mg QD to 45 mg QD | Povorcitinib 75 mg QD to 75 mg QD |
|---|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/34 | 0/33 | 0/34 | 0/35 | 0/9 | 0/7 | 0/10 | 0/29 | 0/30 | 1/32 |
| Activated partial thromboplastin time prolongedInvestigations | 1/34 | 0/33 | 0/34 | 0/35 | 0/9 | 0/7 | 0/10 | 0/29 | 0/30 | 0/32 |
| Bile duct stenosisHepatobiliary disorders | 1/34 | 0/33 | 0/34 | 0/35 | 0/9 | 0/7 | 0/10 | 0/29 | 0/30 | 0/32 |
| Major depressionPsychiatric disorders | 1/34 | 0/33 | 0/34 | 0/35 | 0/9 | 0/7 | 0/10 | 0/29 | 0/30 | 0/32 |
| Event | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD | Placebo to Povorcitinib 15 mg | Placebo to Povorcitinib 45 mg | Placebo to Povorcitinib 75 mg | Povorcitinib 15 mg QD to 15 mg QD | Povorcitinib 45 mg QD to 45 mg QD | Povorcitinib 75 mg QD to 75 mg QD |
|---|---|---|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 2/34 | 2/33 | 1/34 | 5/35 | 2/9 | 2/7 | 0/10 | 3/29 | 4/30 | 4/32 |
| AcneSkin and subcutaneous tissue disorders | 1/34 | 2/33 | 2/34 | 7/35 | 0/9 | 0/7 | 0/10 | 2/29 | 4/30 | 2/32 |
| COVID-19Infections and infestations | 1/34 | 1/33 | 1/34 | 1/35 | 0/9 | 0/7 | 0/10 | 3/29 | 2/30 | 5/32 |
| HeadacheNervous system disorders | 3/34 | 2/33 | 5/34 | 3/35 | 0/9 | 0/7 | 1/10 | 2/29 | 1/30 | 1/32 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/34 | 0/33 | 0/34 | 0/35 | 0/9 | 1/7 | 0/10 | 1/29 | 0/30 | 1/32 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 0/34 | 0/33 | 0/34 | 0/35 | 0/9 | 1/7 | 0/10 | 0/29 | 0/30 | 0/32 |
| Gastroenteritis viralInfections and infestations | 0/34 | 0/33 | 0/34 | 0/35 | 0/9 | 1/7 | 0/10 | 0/29 | 0/30 | 0/32 |
| HypermetropiaEye disorders | 0/34 | 0/33 | 0/34 | 0/35 | 0/9 | 1/7 | 0/10 | 0/29 | 0/30 | 0/32 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/34 | 1/33 | 0/34 | 0/35 | 1/9 | 1/7 | 0/10 | 0/29 | 0/30 | 2/32 |
| ToothacheGastrointestinal disorders | 0/34 | 0/33 | 0/34 | 1/35 | 0/9 | 1/7 | 0/10 | 0/29 | 0/30 | 1/32 |
| Age, Continuous(years) | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD | Total |
|---|---|---|---|---|---|
| Mean | 40.6 ± 12.59 | 37.2 ± 11.51 | 40.8 ± 12.01 | 41.4 ± 11.00 | 40.0 ± 11.77 |
| Sex: Female, Male(Participants) | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD | Total |
|---|---|---|---|---|---|
| Female | 26 | 28 | 28 | 27 | 109 |
| Male | 8 | 5 | 6 | 8 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 2 | 4 | 10 |
| Not Hispanic or Latino | 30 | 31 | 32 | 31 | 124 |
| Unknown or Not Reported | 0 | 2 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Placebo | Povorcitinib 15 mg QD | Povorcitinib 45 mg QD | Povorcitinib 75 mg QD | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 1 | 3 | 2 | 2 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 1 | 2 | 7 |
| White | 31 | 27 | 31 | 31 | 120 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Povorcitinib