Povorcitinib for Chronic Spontaneous Urticaria

No longer recruiting at 55 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must be taking: Second-generation H1 antihistamines

Must not be taking: Anti-IgE biologics

Disqualifiers: Pregnancy, Thrombocytopenia, Malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of povorcitinib, a potential new drug, for adults with chronic spontaneous urticaria (CSU) unresponsive to standard treatments. Participants will receive either a placebo or one of three doses of povorcitinib to determine the most effective option. It suits individuals who have experienced CSU for at least three months and continue to have symptoms despite antihistamine use. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group, providing participants an opportunity to contribute to important early-stage research.

Will I have to stop taking my current medications?

You will need to stay on a stable dose of your current second-generation H1 antihistamine throughout the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that povorcitinib is generally safe for people. In earlier studies, its safety profile matched previous findings. Participants tolerated the treatment well, and while some side effects occurred, they aligned with past data. This indicates that side effects may arise, but they are neither surprising nor unusually severe. Researchers are carefully studying povorcitinib for safety, closely monitoring any risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic spontaneous urticaria?

Researchers are excited about povorcitinib for chronic spontaneous urticaria because it targets the condition differently than current treatments like antihistamines, corticosteroids, or omalizumab. Povorcitinib is a Janus kinase (JAK) inhibitor, which means it works by blocking specific enzymes involved in the inflammatory process, potentially reducing symptoms more effectively. Unlike existing options that may take weeks to show results, povorcitinib could offer quicker relief due to its unique mechanism of action. Additionally, its oral administration could provide a more convenient option for patients compared to injectable treatments.

What evidence suggests that povorcitinib might be an effective treatment for chronic spontaneous urticaria?

Research shows that povorcitinib may help treat chronic spontaneous urticaria (CSU). Studies have found that this drug can significantly reduce itching in just four weeks. In another condition, povorcitinib achieved strong results, suggesting it might be effective. Early findings from another study showed that more patients taking povorcitinib had a 75% reduction in symptoms compared to those taking a placebo. This trial will evaluate different doses of povorcitinib, with some participants initially receiving a placebo, followed by randomization to either Dose A, B, or C. This evidence suggests povorcitinib could work for people whose CSU isn't managed by standard treatments. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults with Chronic Spontaneous Urticaria (CSU) not responding well to standard antihistamines can join. They must have had CSU for at least 3 months, be on a stable dose of second-generation H1 antihistamine, and stick to their current treatment plan during the trial. People with other chronic itching diseases or who've used certain biologics recently can't participate.

Inclusion Criteria

My chronic hives don't improve with standard allergy pills.

I have been taking a consistent dose of a second-generation antihistamine and will continue to do so.

I have been diagnosed with chronic spontaneous urticaria for at least 3 months.

Exclusion Criteria

I have no cancer history, except for treated skin cancer or cervical pre-cancer.

My chronic hives have a known cause other than chronic spontaneous urticaria.

I am not pregnant, considering pregnancy, or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive placebo or povorcitinib for a 12-week period

12 weeks

Dose-Ranging Treatment

Participants are randomized to receive Dose A, B, or C of povorcitinib for an additional 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Povorcitinib

Trial Overview The trial is testing Povorcitinib's effectiveness and safety in adults whose CSU isn't controlled by usual treatments. Participants will either receive Povorcitinib or a placebo without knowing which one they're getting to compare results fairly.

How Is the Trial Designed?

Group I: Povorcitinib Dose C Experimental Treatment 1 Intervention

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

Group II: Povorcitinib Dose B Experimental Treatment 1 Intervention

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

Group III: Povorcitinib Dose A Experimental Treatment 1 Intervention

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

Group IV: Placebo followed by Povorcitinib Dose A, B, or C Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Published Research Related to This Trial

In a study of 878 French patients with chronic urticaria, omalizumab (OMA) showed a longer drug survival rate compared to previous studies, with 50% of patients still on treatment 2.4 years after starting.

The main reason for discontinuing OMA was achieving well-controlled disease in 50% of patients, but many were able to restart treatment, indicating its effectiveness in managing chronic urticaria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. Litovsky, J., Hacard, F., Tétart, F., et al.[2023]

In a phase 2b extension study involving 230 patients with chronic spontaneous urticaria (CSU), remibrutinib showed a favorable safety profile, with most adverse events being mild to moderate and not directly related to the treatment.

Remibrutinib provided significant and sustained efficacy, with 55.8% of patients achieving complete response (UAS7 = 0) and 68.0% achieving well-controlled disease (UAS7 ≤6) after 52 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. Jain, V., Giménez-Arnau, A., Hayama, K., et al.[2023]

Tofacitinib, a JAK1/3 inhibitor, showed significant improvement in patients with refractory chronic urticaria (CU) and urticarial vasculitis (UV), even after they had not responded to other treatments.

The use of tofacitinib allowed for the tapering and discontinuation of other medications like cyclosporine and antihistamines, suggesting it may be an effective new treatment option for difficult-to-treat cases of CU and UV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oral tofacitinib in refractory chronic spontaneous urticaria and urticarial vasculitis. Mansouri, P., Mozafari, N., Chalangari, R., et al.[2023]

Recent advances in the classification and management of chronic urticaria emphasize the use of non-sedating H1-antihistamines, which can be administered in standard doses or increased up to four times if necessary, improving patient care.

For patients who do not respond to H1-antihistamines, omalizumab has been identified as a safe and effective treatment option, providing a new avenue for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights and advances in chronic urticaria: a Canadian perspective. Sussman, G., Hébert, J., Gulliver, W., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05936567

NCT05936567 | Study Evaluating the Efficacy and Safety of ... This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

2. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-new-24-week-phase-3-data-stop-hs-clinical-trial

Incyte Announces New 24-Week Phase 3 Data from the ... In addition, at Week 12, more patients treated with povorcitinib compared to placebo, achieved HiSCR75 (a ≥75% reduction from baseline in the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597230/

Therapies for Chronic Spontaneous Urticaria - PubMed Central A case report indicated that 67% of patients maintained the remission of CSU for up to 22 months after discontinuing therapy with dupilumab [160] ...

4. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-presents-new-late-breaking-data-phase-2-study-evaluating

Incyte Presents New Late-Breaking Data from Phase 2 ... “These Phase 2 results, particularly the demonstrated improvement in itch resolution after just four weeks of treatment, are promising for ...

5. thedermdigest.com thedermdigest.com/incytes-povorcitinib-hits-primary-endpoints-in-phase-3-hs-studies/

Incyte's Povorcitinib Hits Primary Endpoints in Phase 3 HS ... Povorcitinib (Incyte) produced statistically significant results for primary endpoints in two Phase 3 Hidradenitis Suppurativa (HS) trials.

6. investor.incyte.com investor.incyte.com/static-files/0a87efd1-7a9c-4d4c-abd8-4d53bb3f39f8

Povorcitinib in Patients with Moderate to Severe ... The burden of chronic spontaneous urticaria is substantial: real-world evidence from ASSURE-CSU. ... P3 data (PN). P2 data (CSU). Page 32. Q&A ...

7. medchemexpress.com medchemexpress.com/povorcitinib.html?srsltid=AfmBOopTmPJSKNL2-7yDoEPD8svGWpQ2cKb3WYuZrNgMazRh5uLavHf2

Povorcitinib (INCB54707) | JAK1 Inhibitor Urticaria|Chronic Spontaneous Urticaria|Chronic Idiopathic Urticaria|Hives|Angioedema|Pruritis ... SAFETY DATA SHEET (SDS). English - EN (252 KB) Français ...

8. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-and-safety-of-povorcitinib-for-adults-with-chronic-spontaneous-urticaria/

Study on the Effects and Safety of Povorcitinib for Adults ... This study investigates the safety and efficacy of the active substance Povorcitinib for adults suffering from Chronic Spontaneous Urticaria ...