ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

Sarcoidosis Clinical Trial

Official title:

ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02348905
• Other study ID #: AMCMAJCUT2014
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: June 20, 2014
• Last updated: January 23, 2015
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Albany Medical College
• Contact: Haroon Chaudhry, MBBS
• Phone: 518-262-1542
• Email: chaudhh[@]mail.amc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must have biopsy-proven sarcoidosis.

2. 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.

3. Both lesions must have a SASI induration score of > 1 and a SASI induration + erythema score of > 2.

4. 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.

5. If a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in diameter.

Exclusion Criteria:

1. Previous toxic or allergic reaction to ACTHAR gel

2. The presence of another skin condition in addition to sarcoidosis that would interfere with the assessment of the sarcoidosis skin lesions.

3. Uncontrolled hypertension.

4. Uncontrolled diabetes.

5. Active infection.

6. A medical condition that, in the opinion of the investigator would place the subject at significant risk by administering ACTHAR gel.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Sarcoidosis
• Sarcoidosis

Intervention

Drug:
• ACTHAR Gel 40 units twice weekly
ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12.
• ACTHAR Gel 80 units twice weekly.
ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in SASI induration & erythema score.		Between week 0 and week 12.	No
Secondary	Photographic change	Photographic change (improved, worse, no change as determined by investigators blinded to the time of the photographs)	Between week 0 and week 12.	No
Secondary	SAT skin module		Between week 0 and week 12.	No
Secondary	DLQI		Between week 0 and week 12.	No
Secondary	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).	Between week 0 and week 12.	No