A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Prurigo Nodularis



Status:Recruiting
Conditions:Allergy, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:March 6, 2019
End Date:October 2020
Contact:Sponsor Clinical Project Manager
Email:studyinfo@kiniksa.com
Phone:17814319100

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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

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

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.

Inclusion Criteria:

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

Exclusion Criteria:

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
We found this trial at
3
sites
Los Angeles, California
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Anniston, Alabama
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Houston, Texas 77004
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