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A Study Examining the Medication Apremilast as Treatment for Chronic Itch

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2017 by Washington University School of Medicine
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03239106
First received: July 28, 2017
Last updated: August 2, 2017
Last verified: August 2017
  Purpose
Chronic Itch is a debilitating condition affecting many people. Currently, there are no FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic arthritis. This study examines if apremiliast taken twice daily relieves chronic itch.

Condition Intervention Phase
Itch Drug: Apremilast Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of Apremilast in Chronic Idiopathic Pruritus

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Absolute change in NRS itch score form Baseline to Week 16 (end of treatment) [ Time Frame: Baseline and Week 16 ]
    Participants will complete a Numeric Rating Scale for itch ( 0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week.


Secondary Outcome Measures:
  • Absolute change in DLQI from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
    Participants will complete a 10 question Dermatology Quality of Life survey at baseline through Week 16

  • NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 [ Time Frame: Screening through Week 18 (follow up visit) ]
    Participants' itch will be measured utilizing the Numeric Rating Scale for itch

  • DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 [ Time Frame: Screening through Week 18 (follow up visit) ]
    Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18.


Other Outcome Measures:
  • Skin RNA-seq (Exploratory endpoint) [ Time Frame: Baseline and Week 16 ]
    Skin biopsies at baseline and Week 16


Estimated Enrollment: 10
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: August 1, 2018
Estimated Primary Completion Date: April 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open label
All participants will receive Apremilast 30 mg BID.
Drug: Apremilast
Apremilast 30 mg BID daily
Other Name: Otezla

Detailed Description:
There is no FDA-approved medication for chronic idiopathic pruritus (CIP). Apremilast has demonstrated notable activity and is approved for treatment in other pruritic inflammatory skin conditions such as psoriasis. The drug is currently being investigated as therapy for atopic dermatitis. Additionally, the investigators have preliminary data to suggest that apremilast's anti-inflammatory properties may work via neuromodulation targeting neuronal cytokine pathways. The proposed study plans to assess the efficacy of apremilast 30 mg BID in the setting of CIP. Durable response to a medication is typically seen within one to two months of starting an efficacious medication in subjects who respond. Therefore, the investigators have designed this study to end at Week 16 to definitively determine efficacy and conclude the study with confidence with regard to both efficacy and failure.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Key Inclusion Criteria: A subject who meets all of the following criteria may be included in the study:

  • Male and non-pregnant, non-lactating female subjects aged 18 years or older
  • Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both Screening and Baseline
  • Diagnosis of CIP for at least 6 weeks prior to screening
  • Willingness to avoid pregnancy or fathering of children
  • Ability and willingness to provide written informed consent
  • Willing and able to comply with all study requirements and restrictions
  • Willing to not participate in any other interventional trial for the duration of their participation
  • Subjects must be in good health as determined by medical history, physical examination, electrocardiogram, clinical laboratory tests and vital signs
  • Failure of a course 2-week course of treatment with topical triamcinolone 0.1% ointment BID
  • Histopathological demonstration of skin eosinophils, mast cell activation, lymphocytic infiltration, and/or dermal edema

Exclusion Criteria:

Key Exclusion Criteria: A subject who meets any of the following criteria will be excluded from the study:

  • Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic dermatitis, psoriasis, etc.)
  • Patients with a prior diagnosis of excoriation disorder
  • Use of topical treatments for CIP (other than bland emollients) within 1 week of Baseline
  • Systemic immunosuppressive or immunomodulating drugs within 4 weeks of Baseline
  • Subjects with cytopenias at screening, defined as:

    • Leukocytes < 3 × 109/L.
    • Neutrophils < lower limit of normal.
    • Lymphocytes < 0.5 × 109/L
    • Hemoglobin < 10 g/dL.
    • Platelets < 100 × 109/L.
  • Unwilling or unable to follow medication restrictions described in Section 5.6.3, or unwilling or unable to sufficiently washout from use of restricted medication
  • Under medical treatment for a skin disease with a therapy listed in the prohibited medications section that may influence the results of the study
  • Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal gastrointestinal, endocrine or metabolic dysfunction unless currently controlled and stable, including (but not limited to) the following: Positive for Hepatitis C antibody test (anti-HCF) Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) Positive for HIV (DUO test, p24 antigen)
  • Active malignancy
  • Active substance abuse or history of substance abuse within 6 months of screening
  • History (including family history) or current evidence of congenital long QT syndrome or known acquired QT prolongation
  • Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit
  • Subjects who had previously received apremilast
  • Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis or at least 1 of the following:

    • Serum creatinine > 1.5 mg/dL
    • Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal
  • Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
  • Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound results.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03239106

Contacts
Contact: Nancy Bodet, RN (314) 273-1376 nbodet@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
Celgene Corporation
Investigators
Principal Investigator: Brian S. Kim, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03239106     History of Changes
Other Study ID Numbers: CIP-ApremilastCC-10004
Study First Received: July 28, 2017
Last Updated: August 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
itch
pruritus
CIP

Additional relevant MeSH terms:
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 22, 2017