Sunlight-mediated Inter-organ Leukocyte Exchange

CompletedNot a drug-phase studyRelapsing MSNCT05627609

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • 311 nm narrowband UVB irradiation

What it measured

Main measures

  • Vitamin D3 serum concentration (ng/mL)

    4 weeks

    How the body handles the medicine

Other measures (1)

  • single-cell RNA sequencing

    1 year

    Blood or spinal fluid markersImmune response

Who could take part

Relapsing MS · 18 to 60

Show the full criteria

Inclusion criteria

* RRMS according to revised McDonald criteria (2017) or healthy volunteer * Patients under treatment of natalizumab, teriflunomide, glatirameracetat or dimethyl fumarate for at least 4 weeks of therapy, or therapy-naïve patients will be included

Exclusion criteria

* Patients receiving treatment in the last 3 months of interferon-β, fingolimod, alemtuzumab, ocrelizumab, cladribine, ofatumumab, ozanimod, or ponesimod * Vitamin D supplementation in the last 8 weeks * UVB-narrowband contraindicated skin diseases (e.g., cutaneous neoplasia) * Lacking the ability to stand on their own in the treatment chamber * Signs of intolerance regarding UVB radiation * Intake of UV-sensitive therapeutics * Further autoimmune diseases (e.g., Morbus Crohn, psoriasis, neurodermatitis) * Additional recreational or therapeutic UV radiation (e.g., solarium)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Ultraviolet B (UVB) irradiation induces regulatory immune cell types that may transmigrate from the skin to the blood and to the central nervous system and exert regulatory effects. Vitamin D deficiency-associated gene variants should reduce this effect if this is mediated by vitamin D. For this study, participants will be irradiated with UVB for 4 weeks. Single cell RNA Sequencing will be performed on isolated immune cells from skin, blood and Cerebrospinal fluid (CSF), before and after irradiation.

Papers

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History

    1. Started

      Nov 2022

    2. Main results due

      Apr 2023

    3. Finished

      Apr 2023

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