A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

  • Skin disease
  • Idiopathic urticaria
  • Chronic idiopathic urticaria
  • Lichen planus
  • Psoriasis
  • Plaque psoriasis
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Country
  • United States
Study Identifier:

NCT03858634 GX45045 KPL-716-C202

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study. The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT03858634, KPL-716-C202, GX45045 Study Identifier
      KPL-716, Placebo Treatments
      Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis Condition
      Official Title

      KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Male or female aged 18 to 75 years
      • Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
      • Moderate to severe pruritus
      • Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
      • Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
      Exclusion Criteria
      • Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
      • Is currently using medication known to cause pruritus
      • Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
      • Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
      • Has an active infection, including skin infection
      • Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results

      For the latest version of this information please go to www.forpatients.roche.com

       

      Related Studies

      Use our search to find other studies on ForPatients in related disease areas.

      Chronic idiopathic urticaria Lichen planus Plaque psoriasis

      Clinical Research Explained

      Information about what clinical studies and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now