Tofacitinib in Patients With Amyotrophic Lateral Sclerosis

Sponsor
Beijing Tiantan Hospital
Study ID
NCT06689982
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib tablets — DRUG
    All patients should be closely monitored for signs and symptoms of infection during and after treatment with tofacitinib tablets. If a patient develops a severe infection, opportunistic infection, or sepsis, medication should be discontinued. During treatment, patients with lymphocyte counts \< 500 cells/mm\^3 or ANC \< 500 cells/mm\^3 confirmed by repeated testing should be stopped. When 500≤ANC≤1000 cells/mm\^3, administration should be interrupted, and if ANC returns to more than 1000 cells/mm\^3, administration should be resumed. When hemoglobin \< 8 g/dL or decreases by more than 2 g/dL, administration should be interrupted until hemoglobin values return to normal.

Study Details

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease, of which motor-neuron's degeneration may be associated with neuroinflammation. Tofacitinib is a Janus kinase (JAK) inhibitor that affects cellular hematopoiesis and cellular immune function. At the same time, tofacitinib is suitable for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This study is a single center, single arm, proof of concept, clinical trial study, and it is planned to use tofacitinib to carry out a clinical trial to observe the treatment effect of ALS patients.

Key Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Dec 1, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    This group will receive tofacitinib citrate sustained-release tablets at 180 consecutive days .

Primary Outcome Measure

Changes of ALSFRS-R scale scores in ALS patients [ Time Frame: day 180±14 ]

Central Contacts

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