A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Condition: Chronic Idiopathic Urticaria; Chronic Idiopathic Pruritus; Lichen Planus; Lichen Simplex Chronicus; Plaque Psoriasis
MeSH terms: Psoriasis; Pruritus; Urticaria; Lichen Planus; Chronic Urticaria; Neurodermatitis
Intervention: KPL-716; Placebo
Intervention description: A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.; Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pruritus, chronic pruritus, moderate to severe

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 18 to 75 years

          2. 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

          3. Moderate to severe pruritus

          4. 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

          5. 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:

          1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of
             Study

          2. Is currently using medication known to cause pruritus

          3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the
             diagnosis that defines inclusion

          4. Laboratory abnormalities that fall outside the windows specified in the protocol at
             the Screening Visit

          5. Has an active infection, including skin infection

          6. 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