The trial is taking place at:
U

Universitatsklinikum Leipzig AoR | Medizinische Klinik III - Rheumatologie

Veeva-enabled site

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

Incyte logo

Incyte

Status and phase

Enrolling
Phase 2

Conditions

Angioedema
Hives
Chronic Spontaneous Urticaria
Urticaria
Pruritis
Chronic Idiopathic Urticaria

Treatments

Drug: Placebo
Drug: Povorcitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05936567
INCB54707-207

Details and patient eligibility

About

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

Enrollment

136 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

136 participants in 4 patient groups

Povorcitinib Dose A
Experimental group
Description:
Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
Treatment:
Drug: Povorcitinib
Povorcitinib Dose B
Experimental group
Description:
Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
Treatment:
Drug: Povorcitinib
Povorcitinib Dose C
Experimental group
Description:
Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
Treatment:
Drug: Povorcitinib
Placebo followed by Povorcitinib Dose A, B, or C
Experimental group
Description:
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.
Treatment:
Drug: Povorcitinib
Drug: Placebo

Trial contacts and locations

39

Loading...

Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems