A Study Examining the Medication Apremilast as Treatment for Chronic Itch
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|ClinicalTrials.gov Identifier: NCT03239106|
Recruitment Status : Not yet recruiting
First Posted : August 3, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Itch||Drug: Apremilast||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study of Apremilast in Chronic Idiopathic Pruritus|
|Anticipated Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||October 1, 2018|
Experimental: open label
All participants will receive Apremilast 30 mg BID.
Apremilast 30 mg BID daily
Other Name: Otezla
- 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.
- 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.
- Skin RNA-seq (Exploratory endpoint) [ Time Frame: Baseline and Week 16 ]Skin biopsies at baseline and Week 16
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): NCT03239106
|Contact: Nancy Bodet, RN||(314) email@example.com|
|Principal Investigator:||Brian S. Kim, MD||Washington University School of Medicine|