A Study Examining the Medication Apremilast as Treatment for Chronic Itch

NCT03239106 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CIP-ApremilastCC-10004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Itch

Keywords

itch; pruritus; CIP

Outcome Measures

Primary Outcomes (1)

• Absolute NRS Itch Score at Week 16 (End of Treatment)

  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. 0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.

  Week 16

Secondary Outcomes (3)

• Absolute DLQI at Week 16

  Week 16

• NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18

  Screening through Week 18 (follow up visit)

• DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18

  Screening through Week 18 (follow up visit)

Study Arms (1)

open label

EXPERIMENTAL

All participants will receive Apremilast 30 mg BID.

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast 30 mg BID daily

Also known as: Otezla

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Celgene Corporation: collaborator

Study Sites (1)

Washington University Division of Dermatology

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Pruritus

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the high dropout rate in this study a meaningful intent-to-treat analysis was not possible. Therefore, in addition, we attempted a last observation carried forward (LOCF) analysis as well.

Results Point of Contact

• Title: Brian Kim, Associate Professor of Medicine
• Organization: Washington University School of Medicine

briankim@wustl.edu

314-273-1376

Study Officials

• Brian S. Kim, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 3, 2017
• Study Start: December 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: September 19, 2019
• Last Updated: July 13, 2021
• Results First Posted: April 20, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)