ACTHAR Gel 80 units twice weekly. for Cutaneous Sarcoidosis

1
Effectiveness
2
Safety
Albany Medical College, Albany, NY
+1 More
ACTHAR Gel 80 units twice weekly. - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cutaneous Sarcoidosis

Study Summary

ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

See full description

Eligible Conditions

  • Sarcoidosis
  • Cutaneous Sarcoidosis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether ACTHAR Gel 80 units twice weekly. will improve 1 primary outcome and 4 secondary outcomes in patients with Cutaneous Sarcoidosis. Measurement will happen over the course of Between week 0 and week 12..

Week 12
DLQI
Extent of granulomatous inflammation in the biopsy lesion
Photographic change
SAT skin module
The change in SASI induration & erythema score.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
ACTHAR Gel 80 units twice weekly

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. ACTHAR Gel 80 Units Twice Weekly. is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

ACTHAR Gel 80 units twice weekly
Drug
ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12.
ACTHAR Gel 40 units twice weekly
Drug
ACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: between week 0 and week 12.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly between week 0 and week 12. for reporting.

Who is running the study

Principal Investigator
M. A. J.
Marc A. Judson, MD
Albany Medical College

Closest Location

Albany Medical College - Albany, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

Ask a question about the study

Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Cutaneous Sarcoidosis by sharing your contact details with the study coordinator.