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Status:

RECRUITING

Baricitinib in the Treatment of Kohlmeier-Degos Disease in Patients With Neurological Involvement

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Kohlmeier-Degos Disease

Malignant Atrophic Papulosis

Eligibility:

All Genders

18-99 years

Phase:

PHASE2

Brief Summary

Background: Kohlmeier-Degos (KD) is a rare disease that causes inflammation and blood clots, leading to blockages in small blood vessels. These blockages can result in K-D lesions throughout the body...

Detailed Description

Study Description: This phase II study will provide off-label baricitinib treatment in patients with Kohlmeier Degos disease (K-D) with neurologic involvement. We will perform a baseline research eva...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 14 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 15 2030

    Estimated Enrollment :

    12 Patients enrolled

    Trial Details

    Trial ID

    NCT06923072

    Start Date

    January 14 2026

    End Date

    December 15 2030

    Last Update

    January 9 2026

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892