ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
1 other identifier
interventional
10
1 country
1
Brief Summary
ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 28, 2015
January 1, 2015
4 months
June 20, 2014
January 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The change in SASI induration & erythema score.
Between week 0 and week 12.
Secondary Outcomes (4)
Photographic change
Between week 0 and week 12.
SAT skin module
Between week 0 and week 12.
DLQI
Between week 0 and week 12.
Extent of granulomatous inflammation in the biopsy lesion
Between week 0 and week 12.
Study Arms (2)
ACTHAR Gel 40 units twice weekly
EXPERIMENTALACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12.
ACTHAR Gel 80 units twice weekly
EXPERIMENTALACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12.
Interventions
ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12.
ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12.
Eligibility Criteria
You may qualify if:
- Patients must have biopsy-proven sarcoidosis.
- a) Patients with active cutaneous sarcoidosis and two active lesions on stable therapy or no therapy for at least two months AND/OR b) Patients with active cutaneous sarcoidosis and lupus pernio lesions on stable therapy or no therapy for at least two months. A maximum of 5 patients may be enrolled fulfilling criterion b) above.
- Both lesions must have a SASI induration score of \> 1 and a SASI induration + erythema score of \> 2.
- If two lesions are present, one must be \> 1cm in diameter and the subject must be willing to have it biopsied. The second lesion must be at least 0.5 cm in diameter.
- If a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in diameter.
You may not qualify if:
- Previous toxic or allergic reaction to ACTHAR gel
- The presence of another skin condition in addition to sarcoidosis that would interfere with the assessment of the sarcoidosis skin lesions.
- Uncontrolled hypertension.
- Uncontrolled diabetes.
- Active infection.
- A medical condition that, in the opinion of the investigator would place the subject at significant risk by administering ACTHAR gel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albany Medical College
Albany, New York, 12208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc A Judson, MD
Albany Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Marc A. Judson, MD
Study Record Dates
First Submitted
June 20, 2014
First Posted
January 28, 2015
Study Start
March 1, 2015
Primary Completion
July 1, 2015
Study Completion
January 1, 2016
Last Updated
January 28, 2015
Record last verified: 2015-01