Do you have patients with CPUO?

Introducing the Chronic Itch Study

The Chronic Itch Study is a phase 2, multi-center, parallel group, randomized, double-blind, placebo-controlled exploratory proof of concept study designed to assess the pharmacokinetics (PK)/pharmacodynamics (PD) relationship of an investigational medication.

Chronic Pruritus of Unknown Origin (CPUO) is defined as an itch lasting longer than 6 weeks without underlying systemic, dermatologic, or neuropathic etiologies. CPUO is a burdensome and serious condition with an unmet need, as there are no United States (US) Food and Drug Administration (FDA) approved treatments specifically for CPUO.

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Key eligibility criteria

  1. Male or female, aged 18 years or older at the time of informed consent
  2. Clinical diagnosis of chronic pruritus on normal-appearing skin for at least 6 months before the screening visit
  3. Experiencing pruritus affecting at least 4 of the following body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior trunk, posterior trunk
  4. A history of insufficient control of the chronic pruritus with prior treatment
  5. Experienced a weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥ 7 in the week immediately prior to the baseline visit
  6. Able and willing to meet all study requirements in the opinion of the Investigator, including travel to study center, procedures, measurements, and visits

    Other eligibility criteria will be assessed by the study team.

What does study participation involve?

Enrolling in the study: Participants will be given all the details about participation, including potential benefits and risks. Then, the study team will perform tests to determine if this study is a good fit.

Study duration: Participants will be in the study for up to 28 weeks through a 2 to 4-week screening period, a 16-week intervention (treatment) period, and an 8-week follow-up period.

Study tests and procedures: There are many tests in this study, including blood tests, ECGs, and complete physical examinations. The study team will explain these tests and their frequency in more detail.

Study medication: The investigational medication will be compared to a placebo, which does not have any active medication in it. Participants will be randomly assigned to receive either the investigational medicine or a placebo by subcutaneous (SC) injection.

Investigational medication

The investigational medication is a humanized monoclonal antibody recognizing the IL-31 receptor alpha chain (IL-31RA). The investigational medication has demonstrated efficacy in reducing itch in other conditions, including PN and AD. This may potentially improve pruritus symptoms, as well.

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Study design

Approximately 50 participants with CPUO will be randomized 4:1 to receive either the investigational medication or placebo by subcutaneous (SC) injection.

What does study participation involve?

Participants will be in the study for up to 28 weeks (about 7 months) throughout the following periods:

  • Screening Period: For 2-4 weeks participants will have tests done to determine if they are eligible, including complete physical examination, blood samples, and 12-lead ECG.
  • Treatment Period: Participants will receive their assigned study medicine and be monitored by the study team for 16 weeks.
  • Follow-up Period: 8 weeks after the Treatment Period participants will have a follow-up visit during which tests will be done, including complete physical examination and blood tests.
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What’s included in study participation?

Eligible participants will receive the investigational medication and/or other study medication (or placebo), all study-related medical assessments and laboratory tests, and regular medical monitoring and care related to the study.

Participants will also receive reimbursement for expenses related to attending study visits, such as travel and meal costs. More detailed information as to how much participants may be reimbursed will be provided by a member of the study team.

Refer your patients to the Chronic Itch Study

Thank you for considering this study for your patients with CPUO. For more information or to refer a patient, please contact the study team.

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