Trial Outcomes & Findings for Safety and Efficacy of CC-10004 for Prurigo Nodularis (NCT NCT00869089)
NCT ID: NCT00869089
Last Updated: 2016-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
24 weeks
Results posted on
2016-11-02
Participant Flow
Enrollment was open from September 2008 through 2009. Study visits were conducted in outpatient Dermatology clinic.
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.
Participant milestones
| Measure |
CC-10004
CC-10004 treatment:
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
CC-10004
CC-10004 treatment:
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Fail
|
1
|
Baseline Characteristics
Safety and Efficacy of CC-10004 for Prurigo Nodularis
Baseline characteristics by cohort
| Measure |
CC-10004
n=5 Participants
CC-10004 Treatment
|
|---|---|
|
Age, Customized
Age < 18
|
0 participants
n=5 Participants
|
|
Age, Customized
Age > or = 18
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Subjects who completed the study were analyzed.
Outcome measures
| Measure |
CC-10004
n=2 Participants
CC-10004 treatment
|
|---|---|
|
Improvement in Prurigo Nodularis
Response to treatment
|
0 participants
|
|
Improvement in Prurigo Nodularis
Minimal or no response to treatment
|
2 participants
|
Adverse Events
CC-10004
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CC-10004
n=5 participants at risk
CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Headaches
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Prurigo Nodularis Flare
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Worsening of peripheral neuropathy
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Conjunctival hemorrhage
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
GI upset
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Tongue tenderness
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Influenza
|
20.0%
1/5 • Number of events 1
|
Additional Information
Neil J. Korman, MD Principal Investigator
University Hospitals Case Medical Center
Phone: 216-844-7164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place