Safety and Efficacy of CC-10004 for Prurigo Nodularis

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00869089
• Collaborator: Celgene Corporation (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 28
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This trial will include:

• Study period up to 7 months.

• Office visits monthly lasting approximately 1 hour.

• Blood Draws.

• Oral medication that is taken 2 times daily.

• Photographs and biopsies if agreed.

Condition or Disease	Intervention/Treatment	Phase
Prurigo Nodularis	Drug: CC-10004	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Single Center Study to Assess the Safety and Efficacy of a 24 Week Treatment Course of CC-10004 in Adults With Recalcitrant Nodularis
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CC-10004 CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)	Drug: CC-10004; 30mg,oral medication, BID, for 24 weeks (60mg total DAILY); Other Names: apremilast

Outcome Measures

Primary Outcome Measures

1. Improvement in Prurigo Nodularis [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must understand and voluntarily sign an informed consent form

• Must be male or female and aged ≥ 18 years at time of consent

• Must be able to adhere to the study visit schedule and other protocol requirements

• Must have a diagnosis of prurigo nodularis based on clinical and histological findings and have failed four weeks of treatment with topical therapies, including corticosteroids and/or vitamin D derivatives.

• Must meet the following laboratory criteria:

• Hemoglobin WNL

• Hematocrit WNL

• White blood cell (WBC) count WNL

• Neutrophils ≥ 1500 /dL

• Platelets ≥ 100,000 /dL

• Serum creatinine ≤ 1.5 mg/dL

• Total bilirubin 2.0 mg/dL

• Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) 1.5x upper limit of normal (ULN)

• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.

• Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.

Exclusion Criteria:

• History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the investigator

• Any systemic treatment (including ultraviolet light, corticosteroids, thalidomide, azathioprine, cyclosporine) within 28 days of study drug administration.

• Any topical treatments (including corticosteroids, vitamin D derivatives) within 14 days of study drug initiation.

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

• Pregnant or lactating female.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center
• Celgene Corporation

Investigators

• Principal Investigator: Neil Korman, M.D.,PhD., University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neil Korman, Principle Investigator, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT00869089
• Other Study ID Numbers: 102652; 12-07-24
• First Posted: Mar 25, 2009
• Last Update Posted: Nov 2, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Neil Korman, Principle Investigator, University Hospitals Cleveland Medical Center: PN
• Additional relevant MeSH terms: Prurigo; Neurodermatitis; Apremilast

Study Results

Participant Flow

Recruitment Details	Enrollment was open from September 2008 through 2009. Study visits were conducted in outpatient Dermatology clinic.
Pre-assignment Detail	This was an open label single site study for adults with recalcitrant prurigo nodularis. Participants must have failed 4 weeks of treatment with topical corticosteroids or vitamin D derivatives.

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004 treatment: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Period Title: Overall Study
STARTED	5
COMPLETED	2
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004 Treatment
Overall Participants	5
Age, Customized (participants) [Number]
Age < 18	0 0%
Age > or = 18	5 100%
Sex: Female, Male (Count of Participants)
Female	3 60%
Male	2 40%

Outcome Measures

1. Primary Outcome

Title	Improvement in Prurigo Nodularis
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Subjects who completed the study were analyzed.

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004 treatment
Measure Participants	2
Response to treatment	0 0%
Minimal or no response to treatment	2 40%

Adverse Events

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
All Cause Mortality
	CC-10004
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CC-10004
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	CC-10004
	Affected / at Risk (%)	# Events
Total	4/5 (80%)
Eye disorders
Conjunctival hemorrhage	1/5 (20%)	1
Gastrointestinal disorders
Nausea	1/5 (20%)	1
GI upset	1/5 (20%)	1
General disorders
Headaches	1/5 (20%)	1
Tongue tenderness	1/5 (20%)	1
Infections and infestations
Influenza	1/5 (20%)	1
Metabolism and nutrition disorders
Hypomagnesemia	1/5 (20%)	1
Nervous system disorders
Worsening of peripheral neuropathy	1/5 (20%)	1
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection	1/5 (20%)	1
Skin and subcutaneous tissue disorders
Prurigo Nodularis Flare	1/5 (20%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.