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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

23 Nov 2023 → 9 Oct 2025

Decision date (initial)

2023-10-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Dose response, Pharmacokinetic, Safety, Therapy

To evaluate the efficacy of povorcitinib in adult participants with CSU.

Secondary objectives 1

1. To further evaluate the efficacy of povorcitinib in adult participants with CSU.

Conditions and MedDRA coding

Chronic Spontaneous Urticaria

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Age 18 to 65 years inclusive at the time of signing the ICF.
3. CSU diagnosis for ≥ 3 months prior to screening.
4. CSU refractory to second-generation H1 antihistamines as defined in section 5.1, line 4 of the protocol.
5. Willingness and ability to comply with the study Protocol and procedures.
6. Willingness and ability to complete daily eDiary for the duration of the study.
7. Agreement to use contraception (as per section 5.1 of the protocol).

Exclusion criteria 19

1. Treatment with an anti-IgE biologic (eg, omalizumab) within 8 weeks prior to screening.
2. History of treatment failure with any systemic or topical JAK inhibitor (eg, abrocitinib, baricitinib, brepocitinib, cerdulatinib, delgocitinib, deucravacitinib, filgotinib, ivarmacitinib, pacritinib, ritlecitinib, ropsacitinib, ruxolitinib, tofacitinib, upadacitinib) for CSU or any other inflammatory condition.
3. Receipt of medical treatment or investigational drugs within the intervals (specified in section 5.2 of the protocol) before the baseline visit (Day 1).
4. Concurrent enrollment in another clinical study.
5. At the screening visit, any of the laboratory abnormalities defined in Table 6 of section 5.2 of the protocol.
6. Evidence of infection with Mycobacterium tuberculosis (ie, TB).
7. Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as confirmed positive anti-HIV antibody test.
8. Evidence of HBV or HCV infection or risk of reactivation.
9. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class
10. Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.
11. Clearly defined predominant or sole trigger of chronic urticaria (chronic inducible urticaria) including urticaria factitial (symptomatic demographism), cold-, heat-, solar-, pressure-, delayed pressure–, aquagenic, cholinergic-, or contact-urticaria.
12. Other cutaneous or systemic diseases with symptoms of urticaria or angioedema.
13. Other skin or systemic diseases associated with chronic itching (eg, AD, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis) that, in the investigator's opinion, might influence the study evaluations and results.
14. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
15. Concurrent conditions or history of other diseases (as per section 5.2 of the protocol).
16. A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute MI, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff-Parkinson-White syndrome) or criteria associated with Q wave interval (QT)/Fridericia-corrected Q wave interval (QTcF) abnormalities.
17. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
18. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
19. Participants who have any form of dependence on the sponsor, investigator, or study site (including financial) and participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in the UAS7, defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at Week 12.

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 6

Locations

2 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications