Using baricitinib to treat Kohlmeier-Degos disease with neurological symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial aims to evaluate the efficacy of baricitinib, an FDA-approved medication, in patients suffering from Kohlmeier-Degos disease (KD) who exhibit neurological involvement. Participants aged 18 and older will undergo a series of evaluations, including imaging and lumbar punctures, before receiving baricitinib for 24 weeks, alongside their usual medications. The study will assess the progression of neurological symptoms and patient-reported outcomes over a total of 40 weeks. The hypothesis is that baricitinib will reduce disease progression by targeting specific immune signaling pathways.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form by the subject or Legally Authorized Representative (LAR).
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 18 or older.
* Subjects diagnosed with systemic Degos disease, who manifest neurologic abnormalities observed clinically, radiologically or in abnormal laboratory findings.
* Ability to take oral medication and be willing to adhere to the baricitinib regimen.
* For female patients of reproductive potential, non-pregnant, non-breastfeeding: agree to use of highly effective contraception for the duration of the study and 30 days after the last dose.
* Ability of subject or LAR to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

* Active infection not responding to appropriate therapy
* Hemoglobin \<7 g/dL
* Platelet counts \< 50 K /mcL
* Neutropenia (ANC \<0.5 x k/mcL)
* Lymphopenia (Absolute Lymphocyte Count \[ALC\] \<0.2x k/mcL)
* Liver function tests (LFTs \> 2x time upper limit of normal)
* Estimated Glomerular Filtration Rate (eGFR)/Creatinine (Cr \< 30 mL/min)
* Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism \[PE\]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
* Have had symptomatic herpes zoster infection within 12 weeks prior to a enrolling in the study .
* Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
* Have evidence of active TB or latent TB
* Have been exposed to a live vaccine within 12 weeks of baricitinib treatment or are expected to need/receive a live vaccine during the course of the study
* No gadolinium based contrast agent exposure is permitted if eGFR \< 30 mL/min/1.73m\^2 using the CKD-EPI equation measured within 5 days .
* Breast feeding
* Pregnancy
* Uncontrolled malignancy

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Cornelia D Cudrici, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Ruth C Brower, R.N.
• Email: ruth.brower@nih.gov
• Phone: (301) 443-6036

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

  This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.

  Recruiting Phase 1 AbbVie · Grayslake, Illinois · NCT07843693

• Baricitinib for persistent low platelets after stem cell transplant

  We’re testing baricitinib to see if it can help people with long-term low platelets after an allogeneic stem cell transplant who didn’t respond to other treatments.

  Recruiting Phase 1/2 Peking University People's Hospital · Beijing, Beijing Municipality · NCT07535645

• Telitacicept plus baricitinib for refractory rheumatoid arthritis

  This test tries combining telitacicept with baricitinib to see if it helps adults with refractory rheumatoid arthritis who haven't improved on other treatments.

  Recruiting Zhejiang Provincial People's Hospital · Hangzhou, Zhejiang · NCT07491016

• Baricitinib Added to Corticosteroids in PMR (Polymyalgia Rheumatica) May Improve Control

  This study tests whether baricitinib plus low-dose steroids works better than steroids alone for people 50 and older with PMR.

  Recruiting at 19 sites Phase 3 University Hospital, Brest · Aix-en-Provence and 22 other locations · NCT07279688

• Baricitinib for people with STAT3‑related Hyper‑IgE (Job) syndrome who have lupus-like disease or atopic dermatitis

  This trial will test whether the JAK inhibitor baricitinib can be taken safely and may reduce lupus-like symptoms or severe eczema in people aged 12 and older with STAT3-related Hyper‑IgE (Job) syndrome.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07262983

• Baricitinib to preserve insulin-producing beta cells in people newly diagnosed with type 1 diabetes

  This trial will test whether the drug baricitinib can help preserve insulin-producing beta cells in children and adults who were recently diagnosed with type 1 diabetes.

  Recruiting at 108 sites Phase 3 Eli Lilly and Company · Aurora, Colorado and 129 other locations · NCT07222332

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.