Could an arthritis drug stop a deadly skin condition?

NCT ID NCT07708038

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Recruitment status, easiest to join first

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This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests whether tocilizumab, an anti-inflammatory drug, can stop the progression of calciphylaxis—a rare condition where calcium buildup blocks skin blood vessels, causing painful, non-healing wounds. Ten adults with calciphylaxis and end-stage kidney disease will receive three intravenous doses over 16 weeks. The study focuses on safety and whether the drug can reduce wound size and inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab, an anti-inflammatory drug that blocks interleukin-6 (IL-6)
What this could lead to
If it works, this could point toward the first FDA-approved treatment for calciphylaxis, a rare and often fatal condition with no approved therapies.
What could go wrong
This is a very early, small Phase 1 trial with only 10 participants, so results may not apply broadly. The drug also carries risks of serious infections and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2027

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have a clinical diagnosis of calciphylaxis (calcific uremic arteriolopathy) as determined by a board-certified dermatologist or surgeon. * Diagnosis must be supported by either: * Histopathology: A skin biopsy showing characteristic medial arteriolar calcification, subintimal fibrosis, or microvascular thrombosis. * Clinical Presentation: In cases where a biopsy is clinically contraindicated, the presence of characteristic ischemic or necrotic skin lesions in a distribution typical for calciphylaxis (e.g., adipose-rich areas like the abdomen, thighs, or buttocks). * Must have advanced kidney disease, defined as: * End-Stage Kidney Disease (ESKD): Requiring maintenance hemodialysis or peritoneal dialysis. * Chronic Kidney Disease (CKD): Stage 4 or 5 \[estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m²\]. * Participants must be able to understand and provide written informed consent. in accordance with local institutional and regulatory guidelines. * Subjects of childbearing potential must agree to use highly effective contraception for the duration of the study and for at least 3 months following the final dose of Tocilizumab. * Must be willing to undergo blood draws for systemic biomarker analysis (CRP, sTF) as outlined in the study schedule, and safety monitoring. Exclusion Criteria: * Presence of any active, clinically significant infection (bacterial, viral, fungal, or opportunistic) that, in the opinion of the investigator, would pose an unacceptable risk to the patient during IL-6 inhibition. * Known history of diverticulitis, intestinal perforation, or active gastrointestinal ulceration, due to the increased risk of GI perforation associated with tocilizumab. * Evidence of active tuberculosis (TB) or untreated latent TB \[confirmed via positive Interferon-Gamma Release Assay (IGRA) or purified protein derivative (PPD) skin test\]. * Evidence of active Hepatitis B \[HBsAg positive, or HBcAb positive with detectable hepatitis B virus (HBV) DNA) or active Hepatitis C (HCV RNA positive\] * Absolute Neutrophil Count (ANC) \< 1,500 cells/mm³. * Platelet count \< 100,000 cells/mm³. * Hemoglobin \< 8.0 g/dL. * Baseline elevations of (alanine aminotransferase test (ALT) or aspartate aminotransferase test (AST) \> 1.5 times the upper limit of normal (ULN). * Known active malignancy or a history of malignancy within the last 5 years (excluding successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix). * History of multiple sclerosis or other central demyelinating disorders. * Recent or planned use of other biological response modifiers (e.g., tumor necrosis factor (TNF)-alpha inhibitors, IL-1 receptor antagonists, or B-cell depleting agents) within 3 months prior to enrollment. * Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or planned vaccination during the study period and for 4 weeks following the final dose. * Known hypersensitivity to tocilizumab or any of its excipients. * Pregnant or breastfeeding women, or those planning to become pregnant during the study period. * Individuals who are unable to provide personal informed consent and do not have a Legally Authorized Representative (LAR) available to provide consent on their behalf * Any other concurrent medical or psychiatric condition that, in the investigator's judgment, would make the subject inappropriate for the study or interfere with safety evaluations. * Prisoners

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

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