CLINICAL TRIAL

Siponimod for Sclerosis

Recruiting · < 18 · All Sexes · Ciudad de Mexico, Mexico

This study is evaluating whether ofatumumab and siponimod are more effective than fingolimod in treating multiple sclerosis in children.

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About the trial for Sclerosis

Eligible Conditions
Sclerosis · Multiple Sclerosis

Treatment Groups

This trial involves 3 different treatments. Siponimod is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Ofatumumab
DRUG
+
Ofatumumab placebo
OTHER
Experimental Group 2
Siponimod
DRUG
+
Siponimod placebo
OTHER
Control Group 3
Fingolimod
DRUG
+
Fingolimod placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and younger. You must have received 1 prior treatment for Sclerosis or the other condition listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
EDSS score of 0 to 5.5, inclusive
At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-dose Month 3, 5 and Month 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-dose Month 3, 5 and Month 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Siponimod will improve 1 primary outcome and 8 secondary outcomes in patients with Sclerosis. Measurement will happen over the course of Day 1, Months 3,6,12,18,24.

Neurofilament light chain (NfL) concentrations
DAY 1, MONTHS 3,6,12,18,24
Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod
Percentage of participants with anti-ofatumumab antibodies
DAY 1, PRE-DOSE MONTHS 2,3,5,6,12,18,24
Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab
Plasma Concentrations of ofatumumab
DAY 1, PRE-DOSE FOR DAY 7, MONTHS 2,3,5,6,12,18,24
Ofatumumab plasma concentrations
Plasma Concentrations of siponimod
DAY 1 (2,3,4,6 H), DAY 3 (2,3,4,6 H), PRE-DOSE FOR MONTHS 1 (PRE, 3H), 3,5,12
Siponimod plasma concentrations
Annualized T2 lesion rate
BASELINE UP TO 24 MONTHS
Number of new/newly enlarged T2 lesions per year
Annualized relapse rate (ARR) as compared to historical interferon β-1a data
BASELINE UP TO 24 MONTHS
Frequency of relapses assessed by the annualized relapse rate (ARR) to historical interferon β-1a data. The ARR is defined as the average number of confirmed relapses per year. The historical data for interferon β-1a will derived from prior phase 3 studies.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get sclerosis a year in the United States?

Approximately 17,000 cases are diagnosed with SSc each year in the United States. Of these 10,000 will be diagnosed before the age of 55 and 8,000 will be diagnosed by the age of 65. This condition makes up around 1% of diagnosed health conditions per year.

Anonymous Patient Answer

What are common treatments for sclerosis?

Common options for management of vascular-based disease include the use of oral medications, parenteral medications, surgery, and endovascular therapies. The use of immunosuppressant medications is associated with immune suppression and the increased risk of infections. The type of immunosuppressive agent is associated with immune suppression and the risk of infection. Common options for anti-inflammatory medications include NSAIDs and corticosteroid agents. Although it has traditionally been accepted that the risk of bleeding is higher for corticosteroids, in some cases it is possible for them to be efficacious for certain types of the disease.

Anonymous Patient Answer

What are the signs of sclerosis?

Signs of sclerosis involve the skin and/or bones. These may involve pigmentation of the skin or depigmented areas of the scalp. The skin can also develop scaling or itching. There can be painful joint or pain in the bones. Other signs of sclerosis include loss of hair in areas of the scalp that often have hair. The face can be swollen with signs, including a swollen or painful area around the nose. Signs of sclerosis also often involve other organs, including the eyes. There may be an increased appetite and/or diarrhea or constipation. Other signs may include weight loss, loss of appetite, and vomiting.

Anonymous Patient Answer

What is sclerosis?

Sclerosis refers to the presence of chronic white matter changes, including calcification, atrophy, and narrowing of the brain, spinal cord and cranial nerves. Patients with sclerosis present with cognitive, behavioural and neurological disturbances similar to those of more common neurological diseases, such as Parkinson's and Alzheimer's disease. Physicians may have to consider multiple diseases when evaluating patients for sclerosis. Sclerosis and other white matter changes (predominantly in the brain and spinal cord) may be associated with neuroaxonal spheroids (non-cancerous white matter changes that may mimic a neoplasm). In order to accurately evaluate patients with sclerosis, further investigations may be needed to determine possible concurrent disorders.

Anonymous Patient Answer

Can sclerosis be cured?

Sclerosis of the arteries and venules in the brain can be treated successfully by antiplatelet medications (e.g., aspirin), beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-II blockers when used in low doses with a low-cholesterol diet. The goal of treatment is to minimize the long-term (symptomatic) effects.

Anonymous Patient Answer

What causes sclerosis?

Many patients suffer from scleroderma without receiving any of the treatments which they might have, mainly since these are costly and in the absence of any good and simple way of measuring the disease. It seems that scleroderma follows an autosomic dominant pattern of inheritance, with the heterozygote being more susceptible to this ailment.

Anonymous Patient Answer

What are the latest developments in siponimod for therapeutic use?

Siponimod seems effective in MS, ALS and RA patients with different disease features and different response pattern. It would increase clinical benefit on these patients if the response was a worsening of disease instead of a stabilization. In order to be sure of this response pattern, the following data are required: Siponimod, placebo or standard-of reference drug regimen, a high-adherence protocol, a large number of patients and a long exposure to treat an ongoing disease like MS, ALS or RA.

Anonymous Patient Answer

What is the primary cause of sclerosis?

Lung disease and pneumoconiosis are the most common identifiable causes of non-cardiovascular primary sclerosing pahrhotravers. Tobacco smoking, however, is the major environmental factor for CAD in this population.

Anonymous Patient Answer

What does siponimod usually treat?

There is only one case in which a patient was enrolled by a primary care provider. Further studies are needed to validate and test siponimod's safety in the United States.

Anonymous Patient Answer

Has siponimod proven to be more effective than a placebo?

Siponimod demonstrated significantly more benefit (in terms of time to first A50) than a placebo in this long-term, post hoc open-label, multicenter, Phase 3 clinical trial.

Anonymous Patient Answer

What is the average age someone gets sclerosis?

In England, sclerosis-related deaths in 2011 ranged from 75+ to 84+ years, with a median age of 80.6 years and an interquartile range of 72.2 to 86.0 years.

Anonymous Patient Answer

Does siponimod improve quality of life for those with sclerosis?

There were no differences in mean improvement in physical or mental health between sifonimod or vehicle groups at week 26 of the trial and no exacerbation of symptoms. In general, sifonimod was well tolerated with few adverse events.

Anonymous Patient Answer
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