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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 : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

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

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Pruritis Drug: KPL-716 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: KPL-716
Weekly for 8 weeks
Drug: KPL-716
solution for injection

Placebo Comparator: Placebo
Weekly for 8 weeks
Drug: Placebo
solution for injection




Primary Outcome Measures :
  1. Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) [ Time Frame: Week 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816891


Locations
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Sponsors and Collaborators
Kiniksa Pharmaceuticals, Ltd.
Investigators
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Study Director: John Paolini, M.D. Kiniksa Pharmaceuticals, Ltd.
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Responsible Party: Kiniksa Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03816891    
Other Study ID Numbers: KPL-716-C201
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pruritus
Prurigo
Neurodermatitis
Skin Diseases
Skin Manifestations
Signs and Symptoms
Dermatitis
Skin Diseases, Eczematous