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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816891
Recruitment Status : Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Tracking Information
First Submitted Date  ICMJE January 23, 2019
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Prurigo Nodularis
Official Title  ICMJE 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
Brief Summary Study of the efficacy, safety, tolerability, pharmacokinetics (PK) and immunogenicity of KPL-716 in subjects with prurigo nodularis.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prurigo Nodularis
  • Pruritis
Intervention  ICMJE
  • Drug: KPL-716
    solution for injection
  • Drug: Placebo
    solution for injection
Study Arms  ICMJE
  • Experimental: KPL-716
    Weekly for 8 weeks
    Intervention: Drug: KPL-716
  • Placebo Comparator: Placebo
    Weekly for 8 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 23, 2020)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
100
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03816891
Other Study ID Numbers  ICMJE KPL-716-C201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kiniksa Pharmaceuticals, Ltd.
Study Sponsor  ICMJE Kiniksa Pharmaceuticals, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Paolini, M.D. Kiniksa Pharmaceuticals, Ltd.
PRS Account Kiniksa Pharmaceuticals, Ltd.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP