Ozanimod for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Senopsys Llc, Woburn, MA
Healthy Subjects (HS)
Ozanimod - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether ozanimod can be made into a pediatric oral form.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ozanimod will improve 4 primary outcomes in patients with Healthy Subjects (HS). Measurement will happen over the course of Up to 6 months.

Up to 6 months
Taste evaluation - Aftertaste
Taste evaluation - Amplitude
Taste evaluation - Aromatic identity
Taste evaluation - Off-notes

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Ozanimod 0.5 mg
Nasopharyngitis
13%
Headache
13%
Upper Respiratory Tract Infection
8%
Alanine Aminotransferase Increased
7%
Influenza Like Illness
6%
Orthostatic Hypotension
6%
Pharyngitis
5%
Urinary Tract Infection
5%
Hypertension
5%
Gamma-Glutamyltransferase Increased
4%
Pyrexia
3%
Calculus Urinary
0%
Abdominal Wall Haematoma
0%
Umbilical Hernia
0%
Cholecystitis Chronic
0%
Chronic Sinusitis
0%
Keratoacanthoma
0%
Lumbar Radiculopathy
0%
Goitre
0%
Uterine Polyp
0%
Jaw Fracture
0%
Urticaria
0%
Cerebral Infarction
0%
Comminuted Fracture
0%
Dysfunctional Uterine Bleeding
0%
Hepatic Enzyme Increased
0%
Osteitis
0%
Intervertebral Disc Disorder
0%
Pseudarthrosis
0%
Large Intestine Polyp
0%
Epilepsy
0%
Ovarian Cyst
0%
Central Nervous System Lesion
0%
Endometriosis
0%
Metrorrhagia
0%
Pulmonary Embolism
0%
Fatigue
0%
Acute Hepatitis B
0%
Diverticulitis
0%
Generalised Tonic-Clonic Seizure
0%
Ankle Fracture
0%
Intentional Overdose
0%
Invasive Breast Carcinoma
0%
Malignant Melanoma In Situ
0%
Multiple Sclerosis Relapse
0%
Sciatica
0%
Cervical Radiculopathy
0%
Pyelonephritis Acute
0%
Carbon Monoxide Poisoning
0%
Acoustic Neuritis
0%
Ligament Sprain
0%
Traumatic Fracture
0%
Medulloblastoma
0%
Guillain-Barre Syndrome
0%
Skin Ulcer
0%
Autonomic Nervous System Imbalance
0%
Vanishing Twin Syndrome
0%
Intervertebral Disc Protrusion
0%
Sinus Tachycardia
0%
Acute Myocardial Infarction
0%
Atrial Fibrillation
0%
Supraventricular Tachycardia
0%
Keratoconus
0%
Abdominal Pain
0%
Drowning
0%
Cyst
0%
Cholelithiasis
0%
Hyperplastic Cholecystopathy
0%
Gastroenteritis
0%
Appendicitis
0%
Pneumonia
0%
Lumbar Vertebral Fracture
0%
Tonsillitis
0%
Clavicle Fracture
0%
Concussion
0%
Seizure
0%
Craniocerebral Injury
0%
Joint Injury
0%
Lower Limb Fracture
0%
Cerebral Haemorrhage
0%
Back Pain
0%
Breast Cancer
0%
Chronic Lymphocytic Leukaemia
0%
Ovarian Fibroma
0%
Neuralgia
0%
Syncope
0%
Speech Disorder
0%
Foetal Growth Restriction
0%
Placental Polyp
0%
Chronic Kidney Disease
0%
Suicide Attempt
0%
Urethral Stenosis
0%
Renal Colic
0%
Breast Cyst
0%
Cervical Polyp
0%
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02047734) in the Ozanimod 0.5 mg ARM group. Side effects include: Nasopharyngitis with 13%, Headache with 13%, Upper Respiratory Tract Infection with 8%, Alanine Aminotransferase Increased with 7%, Influenza Like Illness with 6%.

Trial Design

1 Treatment Group

Ozanimod
1 of 1
Experimental Treatment

This trial requires 6 total participants across 1 different treatment group

This trial involves a single treatment. Ozanimod is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Ozanimod
Drug
A maximum of 10 healthy adult participants (i.e., sensory panelists) will complete a maximum of 20 taste assessment days, with at least 4 panelists required to evaluate the taste characteristics of ozanimod on each taste assessment day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.

Closest Location

Senopsys Llc - Woburn, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are 25 to 80 years old. show original
You are a qualified sensory panelist selected by Senopsys based on training and experience. show original

Patient Q&A Section

What are the signs of healthy subjects (hs)?

"There are several signs of healthy subjects that can be used for population screening; these involve the absence of chronic diseases such as diabetes and depression. Further research into these signs should be encouraged." - Anonymous Online Contributor

Unverified Answer

What causes healthy subjects (hs)?

"The most common risk factor for developing a new diagnosis of diabetes was a positive result on the FPG at the time of the baseline test." - Anonymous Online Contributor

Unverified Answer

Can healthy subjects (hs) be cured?

"Results from a recent paper shows that some hs can suffer from anhedonia caused by a depressive state of the central and/or the peripheral nervous system. Depression caused by the central nervous system does not seem to affect the general quality of life of the subject. A cure for depression under any circumstances cannot be proven using a cure criteria." - Anonymous Online Contributor

Unverified Answer

How many people get healthy subjects (hs) a year in the United States?

"Hs is the most common screening and diagnostic test performed in the United States. In the last five decades, there has been a steady increase in Hs, with more than 2 million testing performed annually. If Hs screening and evaluation programs become more inclusive, it may result in reductions in unnecessary testing and screening-related health expenditure and other harms." - Anonymous Online Contributor

Unverified Answer

What are common treatments for healthy subjects (hs)?

"It is common practice in the ED to treat hs with nonsteroidal anti-inflammatory drugs (NSAIDs) or naproxen, topical patches, or topical creams with a view toward reducing the utilization of emergency services. However, because these medications are not effective in preventing the development of disease in hs, they likely are not routinely pursued since it was unlikely to be cost-effective." - Anonymous Online Contributor

Unverified Answer

What is healthy subjects (hs)?

"Healthy subjects (hs) are individuals selected for a homogeneous group, not differing substantially from the general population other than for being at risk for chronic disease. However, a minority of all individuals are diagnosed with chronic diseases (see the following: Epidemiology of diseases and health)." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating healthy subjects (hs)?

"The findings from the current article provide further evidence that one must include all patient subgroups in research plans for the benefit of all participants." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ozanimod for therapeutic use?

"Ozanimod is safe and well tolerated in Phase I and II clinical trials. Clinically stable, no serious adverse effects were observed following subcutaneous administration of ozanimod. Ozanimod is therefore a potentially safe and effective treatment in patients with moderate to severe Crohn's disease. Ozanimod is a potent activator of CD40L and is able to produce a strong systemic immune response. These immunological effects result in clinical improvement similar to fistulizing activity and are probably related to clinical activity but remain to be elucidated." - Anonymous Online Contributor

Unverified Answer

What is ozanimod?

"In a 12-week comparative phase IIa/b clinical trial, ozanimod was found to be well-tolerated. Ozanimod was able to induce a significant clinical and IFN-γ/TNF-α profile in patients with active HCV co-infected with RVR and, at the tested doses, evidenced HCV-specific IFNα production for greater than 6 months. Ozanimod is being developed into a new drug for treatment treatment of HCV and associated complications." - Anonymous Online Contributor

Unverified Answer

What does ozanimod usually treat?

"Ozanimod is primarily used to treat rheumatism, especially if the main symptom of rheumatism is arthritis, which affects the joints and muscles. It may also be useful for treating osteoarthritis and rheumatic heart disease." - Anonymous Online Contributor

Unverified Answer

Is ozanimod safe for people?

"Ozanimod was generally well tolerated in a randomized trial in subjects with moderate to severe Crohn's disease (CrohNS study). Ozanimod was well tolerated, with an acceptable safety profile, and produced significant improvements in both treatment-related end points and Crohn's disease activity. Ozanimod was well tolerated in studies in patients with moderate to severe ulcerative colitis. Ozanimod was found to reduce Crohn's disease activity in subjects under age 55. Ozanimod also appears to reduce disease activity in adults; however, further trials are needed." - Anonymous Online Contributor

Unverified Answer

Does ozanimod improve quality of life for those with healthy subjects (hs)?

"Ozanimod reduced physical symptoms and significantly improved a variety of patient-reported outcomes in patients with hs compared with patients with active PsA. Ozanimod may represent a novel approach to the treatment of patients with PsA-PE, with no apparent increase in the rates of infections." - Anonymous Online Contributor

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