Back to resultsACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
Primary Purpose
Sarcoidosis, Cutaneous Sarcoidosis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACTHAR Gel 40 units twice weekly
ACTHAR Gel 80 units twice weekly.
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Albany Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ACTHAR Gel 40 units twice weekly
ACTHAR Gel 80 units twice weekly
Arm Description
ACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12.
ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12.
Outcomes
Primary Outcome Measures
The change in SASI induration & erythema score.
Secondary Outcome Measures
Photographic change
Photographic change (improved, worse, no change as determined by investigators blinded to the time of the photographs)
SAT skin module
DLQI
Extent of granulomatous inflammation in the biopsy lesion
Extent of granulomatous inflammation in the biopsy lesion (as judged by pathologists blinded to the time of the biopsy).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02348905
Brief Title
ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
Official Title
ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis
Detailed Description
Sarcoidosis is a multisystem granulomatous disease of unknown cause. Although sarcoidosis most commonly affects the lung3, it may affect any organ. Although corticosteroids are recognized as the drug of choice for sarcoidosis, ACTH is the only drug that is FDA-approved for this disorder. However, there is limited data on the efficacy of ACTH for this condition.
Presently, corticosteroids as considered the drug of choice for the treatment of cutaneous sarcoidosis. However, ACTHER GEL not only has obvious anti-inflammatory effects by resulting in corticosteroid production, but it may also activate melanocortin receptors. The melanocortin system has powerful anti-inflammatory properties that may be beneficial in the treatment of cutaneous sarcoidosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Cutaneous Sarcoidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTHAR Gel 40 units twice weekly
Arm Type
Experimental
Arm Description
ACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12.
Arm Title
ACTHAR Gel 80 units twice weekly
Arm Type
Experimental
Arm Description
ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12.
Intervention Type
Drug
Intervention Name(s)
ACTHAR Gel 40 units twice weekly
Intervention Description
ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12.
Intervention Type
Drug
Intervention Name(s)
ACTHAR Gel 80 units twice weekly.
Intervention Description
ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12.
Primary Outcome Measure Information:
Title
The change in SASI induration & erythema score.
Time Frame
Between week 0 and week 12.
Secondary Outcome Measure Information:
Title
Photographic change
Description
Photographic change (improved, worse, no change as determined by investigators blinded to the time of the photographs)
Time Frame
Between week 0 and week 12.
Title
SAT skin module
Time Frame
Between week 0 and week 12.
Title
DLQI
Time Frame
Between week 0 and week 12.
Title
Extent of granulomatous inflammation in the biopsy lesion
Description
Extent of granulomatous inflammation in the biopsy lesion (as judged by pathologists blinded to the time of the biopsy).
Time Frame
Between week 0 and week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haroon Chaudhry, MBBS
Phone
518-262-1542
Email
chaudhh@mail.amc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marc A. Judson, MD
Phone
518-262-5196
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Judson, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haroon Chaudhry, MBBS
Phone
518-262-1542
Email
chaudhh@mail.amc.edu
First Name & Middle Initial & Last Name & Degree
Marc A. Judson, MD
12. IPD Sharing Statement
Learn more about this trial
ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
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