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The trial is taking place at:
C

Centro Internacional de Estudios Clinicos | Santiago, Chile

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A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

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Incyte

Status and phase

Enrolling
Phase 3

Conditions

Prurigo Nodularis

Treatments

Drug: Placebo
Drug: Povorcitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06516965
INCB54707-306

Details and patient eligibility

About

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Enrollment

330 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female participants 18 to 75 years of age.
  • Clinical diagnosis of PN for at least 3 months prior to Screening visit.
  • Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
  • Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
  • Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
  • Willingness to avoid pregnancy or fathering children.

Exclusion criteria

  • Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
  • Diagnosis of PN secondary to medications.
  • Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
  • Women who are pregnant (or are considering pregnancy) or breastfeeding.
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
  • Evidence of infection with TB, HBV, HCV or HIV.
  • History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
  • Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

330 participants in 3 patient groups, including a placebo group

Povorcitinib Dose 1
Experimental group
Description:
Povorcitinib at the protocol-defined dose.
Treatment:
Drug: Povorcitinib
Povorcitinib Dose 2
Experimental group
Description:
Povorcitinib at the protocol-defined dose.
Treatment:
Drug: Povorcitinib
Placebo
Placebo Comparator group
Description:
Placebo at the protocol-defined dose.
Treatment:
Drug: Placebo

Trial contacts and locations

133

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Central trial contact

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

Data sourced from clinicaltrials.gov

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