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Treatments Comparison for Skin Vasculitis
(ARAMIS Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Systemic vasculitis, Auto-immune conditions, Cancer, Infections, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing three different drugs to find the best treatment for patients with isolated skin vasculitis. The drugs help by reducing inflammation and controlling the immune system.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you are taking prednisone for skin vasculitis, you will need to stop it within 6 weeks after starting the study drug, following a specific tapering schedule. If you are on a low and stable dose of glucocorticoids for other conditions, you can continue that dose during the study.

What data supports the effectiveness of the drug for treating skin vasculitis?

Research shows that Dapsone, a component of the treatment, has been effective in treating severe skin vasculitis and other inflammatory skin conditions, leading to remission in some cases. Additionally, Colchicine has been beneficial in managing prolonged skin symptoms in vasculitis, particularly in cases resistant to other treatments.¹ ² ³ ⁴ ⁵

Is the treatment generally safe for humans?

Dapsone has been used safely in humans for various skin conditions, showing anti-inflammatory effects without increasing side effects when combined with other treatments. Azathioprine, however, may have more side effects compared to alternatives like mycophenolate mofetil, which is considered safer.¹ ² ⁶ ⁷ ⁸

How does the drug combination of Azathioprine, Colchicine, and Dapsone differ from other treatments for skin vasculitis?

This drug combination is unique because it combines Azathioprine, known for its safety in treating various skin conditions, with Colchicine and Dapsone, which are effective for chronic or relapsing skin vasculitis and urticarial vasculitis. Dapsone, in particular, has shown success in treating severe and chronic vasculitic ulcerations where other immunosuppressants have failed.¹ ² ⁴ ⁹ ¹⁰

Research Team

Christian Pagnoux, MD, MPH, MSc

Principal Investigator

University of Toronto/Mount Sinai Hospital

Robert Micheletti, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Adults with isolated skin vasculitis, confirmed by biopsy, lasting at least 1 month or having multiple flares. Eligible participants have primary skin vasculitis without serious extra-skin symptoms and may have used steroids before joining. Excluded are those with contraindications to the study drugs, systemic vasculitis signs, active cancer in the last 5 years, severe infections or organ insufficiency.

Inclusion Criteria

I am 18 years old or older.

I have a specific type of skin vasculitis without kidney problems.

I have a skin condition without serious effects on other body parts.

See 5 more

Exclusion Criteria

I cannot take or have not responded to two or three of the drugs in this study.

I have a G6PD deficiency or a history of hemolytic anemia.

My kidneys are not working well, with a creatinine clearance below 60 mL/min.

See 12 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants are randomized to receive one of three medications (colchicine, dapsone, or azathioprine) for 6 months

6 months

Visits at months 1, 3, and 6

Follow-up

Participants are monitored for response to treatment and side effects

6 months

Visits at months 9 and 12

Treatment Stage 2

Participants who discontinue the initial treatment are re-randomized to receive one of the remaining two medications for another 6 months

6 months

Visits at months 1, 3, and 6 of stage 2

Treatment Details

Interventions

Azathioprine (Immunosuppressant)
Colchicine (Anti-inflammatory agent)
Dapsone (Anti-inflammatory agent)

Trial OverviewThe trial is testing three treatments for skin vasculitis: Colchicine, Dapsone, and Azathioprine. It's a multi-center study where patients are randomly assigned to receive one of these standard care options to compare their effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Stage 2Experimental Treatment3 Interventions

If the patient has to discontinue the study drug within the (stage 1) 6 month study period or during the subsequent follow-up period (up to month 12) because of a lack of response (or failure), flare or side effect, he/she will be randomized again to receive one of the remaining two study drugs (stage 2, with a 1:1 randomization ratio, colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint in this second stage will again be the response to treatment at 6 months.

Group II: Stage 1Experimental Treatment3 Interventions

Eligible patients will be initially randomized (1:1:1) to receive one of the 3 medications under investigation (colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint is response to treatment at month 6 (stage 1).

Azathioprine is already approved in Canada for the following indications:

Approved in Canada as Imuran for:

Prevention of rejection in organ transplantation
Treatment of rheumatoid arthritis

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Vanderbilt UniversityNashville, TN

University of Toronto Mount Sinai HospitalToronto, Canada

University of Kansas Medical CenterKansas City, KS

UT Southwestern Medical CenterDallas, TX

More Trial Locations

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Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2118

Patients Recruited

45,270,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Patients Recruited

1,090,000+

Office of Rare Diseases (ORD)

Collaborator

Trials

Patients Recruited

12,400+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Patients Recruited

404,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Refractory cutaneous necrotizing vasculitis. Successful sulfone therapy].Seybold, H., Simon, M., Schuler, G., et al.[2018]

Dapsone, traditionally used for leprosy, showed rapid improvement in two patients with cutaneous dermatomyositis who were unresponsive to other treatments, indicating its potential efficacy in this condition.

Both patients experienced exacerbations of their symptoms upon withdrawal of Dapsone, which improved again when the medication was reintroduced, suggesting a strong therapeutic response linked to Dapsone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous involvement of dermatomyositis can respond to Dapsone therapy.Cohen, JB.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of IgA vasculitis with prolonged cutaneous manifestation with colchicine in a 10-year-old boy.Okura, Y., Hiramatsu, Y., Shimomura, M., et al.[2022]

The treatment approach for leukocytoclastic immune-complex vasculitis (LcV) varies based on the presence of IgA in immune complexes, with IgG- or IgM-associated LcV generally having a better prognosis and often requiring only symptomatic treatment.

In cases of severe conditions like ANCA-associated systemic vasculitis and giant cell arteriitis, rapid and aggressive treatment with glucocorticoids is crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy of vasculitides and vasculopathies].Sunderkötter, C., de Groot, K.[2021]

Dapsone was used to treat chronic purpuric skin lesions in three children with Henoch-Schönlein purpura, leading to fast and complete healing of the lesions.

One child experienced methemoglobinemia, a known side effect of dapsone, emphasizing the importance of careful prescription and monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dapsone for chronic skin lesions in 3 children suffering from Henoch-Schönlein vasculitis].Mazille, N., Lipsker, D., Fischbach, M.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cyclophosphamide in azathioprine failures in pemphigus.Ahmed, AR., Hombal, S.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppressive therapy for autoimmune bullous diseases.Meurer, M.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Urticaria vasculitis and sulfone, a case report].Wozel, G., Thiele, B.[2013]