SarcoidosisPhase 2/3NCT02348905
ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
A Phase 2/3 study testing ACTHAR Gel 40 units twice weekly and ACTHAR Gel 80 units twice weekly. in people with Sarcoidosis and Cutaneous Sarcoidosis, run by Albany Medical College at 1 site in United States.
Trial summary
ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Cutaneous Sarcoidosis
- What is being tested?
- ACTHAR Gel 40 units twice weekly and ACTHAR Gel 80 units twice weekly.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Marc A. Judson, MD contact
United States1 site
Albany Medical College
Albany, New York, 12208
Haroon Chaudhry, MBBS, 518-262-1542, chaudhh@mail.amc.edu
Marc A. Judson, MD
About this study
ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis
Read the 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.
- Conditions
- Sarcoidosis, Cutaneous Sarcoidosis
- Being tested
- ACTHAR Gel 40 units twice weekly, ACTHAR Gel 80 units twice weekly.
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTHAR Gel 40 units twice weeklyDrug
ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12.
ACTHAR Gel 80 units twice weekly.Drug
ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12.
| Study group | Role | What they receive |
|---|---|---|
| ACTHAR Gel 40 units twice weekly | Experimental | ACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12. Receives: Drug: ACTHAR Gel 40 units twice weekly |
| ACTHAR Gel 80 units twice weekly | Experimental | ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12. Receives: Drug: ACTHAR Gel 80 units twice weekly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in SASI induration & erythema score.
Measured: Between week 0 and week 12.
Secondary outcomes (4)
Photographic change
Photographic change (improved, worse, no change as determined by investigators blinded to the time of the photographs)
Measured: Between week 0 and week 12.
SAT skin module
Measured: Between week 0 and week 12.
DLQI
Measured: Between week 0 and week 12.
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).
Measured: Between week 0 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc A. Judson, MD, Albany Medical College
- Investigators
- Marc A Judson, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348905
- Sponsor's protocol ID
- AMCMAJCUT2014
- Status last verified
- Jan 2015
- First submitted
- 20 Jun 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
- ClinicalTrials.gov ID
- NCT02348905
- Acronym / sponsor ID
- AMCMAJCUT2014
- Conditions
- Sarcoidosis, Cutaneous Sarcoidosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTHAR Gel 40 units twice weekly | Experimental | Drug: ACTHAR Gel 40 units twice weeklyACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12. |
| ACTHAR Gel 80 units twice weekly | Experimental | Drug: ACTHAR Gel 80 units twice weekly.ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTHAR Gel 40 units twice weeklyACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12. | Drug | ACTHAR Gel 40 units twice weekly |
| ACTHAR Gel 80 units twice weekly.ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12. | Drug | ACTHAR Gel 80 units twice weekly |
Primary outcome
The change in SASI induration & erythema score.
Time frame: Between week 0 and week 12.
4 secondary outcomes
Photographic change
Time frame: Between week 0 and week 12.
SAT skin module
Time frame: Between week 0 and week 12.
DLQI
Time frame: Between week 0 and week 12.
Extent of granulomatous inflammation in the biopsy lesion
Time frame: Between week 0 and week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A. Judson, MD contact
Marc A Judson, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ACTHAR Gel 40 units twice weekly and ACTHAR Gel 80 units twice weekly. in people with Sarcoidosis and Cutaneous Sarcoidosis, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haroon Chaudhry, MBBS (518-262-1542, chaudhh@mail.amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in SASI induration & erythema score. (time frame: Between week 0 and week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.