Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Timothy Berger

Description

Summary

Study of the efficacy, safety, tolerability, pharmacokinetics (PK) and immunogenicity of KPL-716 in subjects with prurigo nodularis.

Official Title

A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects With Prurigo Nodularis

Details

This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK and immunogenicity of KPL-716 administered subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus. The Phase 2a portion of the study will enroll up to 100 subjects and will include 2 arms: one active arm and one placebo arm.

Following analysis of the Phase 2a portion of the study (milestone dates above), enrollment into the Phase 2b portion may be initiated.

Keywords

Prurigo Nodularis Pruritis Pruritus Prurigo Neurodermatitis KPL-716

Eligibility

You can join if…

Open to people ages 18-75

  1. Male or female aged 18 to 75 years
  2. Have clinical diagnosis of prurigo nodularis for at least 6 months
  3. Have at least 10 nodules at the Screening Visit and Day 1
  4. Moderate to severe pruritus
  5. Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 weeks after final study drug administration
  6. 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

You CAN'T join if...

  1. Use of prohibited medications within the indicated timeframe from Day 1
  2. Is currently using medication known to cause pruritus
  3. Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor
  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 subject 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

Locations

  • Site 122
    San Francisco California 94115 United States
  • Study Site 102
    Los Angeles California 90045 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kiniksa Pharmaceuticals, Ltd.
ID
NCT03816891
Phase
Phase 2
Study Type
Interventional
Last Updated