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A Study to Assess the Efficacy, Safety and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

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: NCT03858634
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Study Description
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Brief Summary:

Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.

The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).


Condition or disease Intervention/treatment Phase
Pruritus Chronic Idiopathic Urticaria Chronic Idiopathic Pruritus Lichen Planus Lichen Simplex Chronicus Plaque Psoriasis Drug: KPL-716 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : June 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arms and Interventions
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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


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


Eligibility Criteria
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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 CIU, CIP, LP, LSC and PPs for at least 6 months
  3. Moderate to severe pruritus
  4. Female participants 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 10 weeks after final study drug administration
  5. 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 to the End of Study
  2. Is currently using medication known to cause pruritus
  3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
  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 participant 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
Contacts and Locations
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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): NCT03858634


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.
More Information
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Responsible Party: Kiniksa Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03858634    
Other Study ID Numbers: KPL-716-C202
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: September 2, 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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Psoriasis
Pruritus
Urticaria
Lichen Planus
Neurodermatitis
Skin Diseases, Papulosquamous
Skin Diseases
Skin Manifestations
 Skin Diseases, Vascular
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lichenoid Eruptions
Dermatitis
Skin Diseases, Eczematous