Scleroderma, Systemic

Period A: patients randomized 1:1 to weekly subcutaneous treatment with 400mg Bermekimab or matched Placebo for 12 weeks

MABp1 (Bermekimab) OR Placebo

Period B: all patients treated weekly with subcutaneous 400mg Bermekimab for 12 weeks

MABp1 (Bermekimab)

Department of Pathophysiology, LAIKO Athens General Hospital

4th Department of Internal Medicine, ATTIKON University Hospital

The Benefit of Bermekimab in Patients With Systemic Sclerosis

Clinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)

A positive score will comprise at least four of the following evaluation elements.
At least 30% decrease of the number of inflamed joints
At least 30% decrease of the number of digital ulcers
At least 30% decrease of the mRSS
At least 50% decrease of the UCLA GIT scoring system
At least 50% increase of the SF-36
At least 50% decrease of VAS for SSc
At least 50% decrease of VAS for fatigue
At least 50% decrease of VAS for dyspnea
Any increase of BMI ( kg/m2 )
Any increase of carbon monoxide diffusing capacity (DLCO)
Any increase of forced vital capacity (FVC)
At least 10% increase of the left ventricle ejection fraction (LVEF)
At least 10% decrease of the pulmonary artery pressure
At least 10% decrease of the capillary density as assessed by NCMT

The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the bermekimab arm The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the placebo arm The comparison of the score of inhibition of SSc progression at week 24 between the two groups of treatment The change of each of the elements of the score of inhibition of SSc progression at week 12 between the two groups of treatment. Comparisons for all qualitative variables of the secondary endpoints will be done by the Fisher exact test. Odds ratio and 95% confidence intervals will be calculated according to Mantel and Haenszel's statistics. Comparisons for all quantitative variables of the secondary endpoints will be done by non-parametric statistics.

Comparative kinetics of endothelin-1 between the two groups of treatment.

Comparative kinetics of VEGF between the two groups of treatment.

Comparative kinetics of TGFβ between the two groups of treatment.

Comparative kinetics of pro-BNP between the two groups of treatment.

Comparative kinetics of HMGB1 between the two groups of treatment.

Comparative kinetics ofIL-1α between the two groups of treatment.

Hellenic Institute for the Study of Sepsis

Patients assigned to either subcutaneous Bermekimab or placebo for 12 weeks ( 1:1 randomization, blind period ), then all patients are assigned to subcutaneous Bermekimab for 12 weeks ( open label period )

15 subjects in each RT dose schedule 10 GY in 5 daily fractions 20 GY in 10 daily fractions

Alzheimer's Disease

10 GY in 5 daily fractions

Subjects 16-30 20 GY in 10 daily fractions

20 GY in 10 daily fractions

Virginia Commonwealth University

Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's

Phase IIa Trial of Low Dose Radiation THerapy to Reduce Cerebral Amyloidosis in Early Alzheimer's Dementia

Evaluate the safety and toxicity/adverse events associated with the delivery of low dose fractionated whole brain irradiation in subjects with early Alzheimer's dementia using CTCAE Version 4.0 and the RTOG toxicity grading system

Patients will complete neurocognitive function tests which will be used to assess any neurocognitive changes, following treatment. Analysis will be completed by a neuropsychology specialist and will be preformed at 6 weeks, 3, 9, 12 months and compared to pretreatment results.

Analysis will be completed by a neuropsychology specialist and will be performed at 6 weeks, 3, 9, 12 months and compared to pretreatment results.

hidradenitis suppurativa/fadiga

The Benefit of Bermekimab in Patients With Systemic Sclerosis

Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's

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