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MT-7117 for Systemic Sclerosis
Phase 2
Waitlist Available
Research Sponsored by Mitsubishi Tanabe Pharma America Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Study Summary
This trial is testing a new treatment for people with a certain type of systemic sclerosis. The treatment will be evaluated based on how much it improves the subjects' condition at Week 52.
Who is the study for?
Adults over 18 with diffuse cutaneous systemic sclerosis (dcSSc) for less than 5 years, who are not pregnant or planning to become pregnant and agree to use two contraception methods. They must have certain levels of skin involvement and signs of active disease if the condition has lasted more than 24 months. Excluded are those recently treated with specific drugs, have had certain therapies, significant other diseases, or a history of malignancies.Check my eligibility
What is being tested?
The trial is testing MT-7117's effectiveness in treating dcSSc compared to a placebo using the ACR CRISS at Week 52. Participants will be randomly assigned to receive either MT-7117 or a placebo and monitored for changes in their condition.See study design
What are the potential side effects?
While specific side effects for MT-7117 aren't listed here, common clinical trial risks may include allergic reactions, injection site discomfort, fatigue, gastrointestinal issues like nausea or diarrhea, headaches, and potential risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The ACR CRISS composite score (0-1) at Week 52
Secondary outcome measures
ACR CRISS Score up to Week 39
ACR CRISS score responder (CRISS>=0.6) from baseline up to week 52
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline up to week 52
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MT-7117Experimental Treatment1 Intervention
Oral tablet of MT-7117 once a day.
Group II: PlaceboPlacebo Group1 Intervention
Oral tablet of placebo once a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MT-7117
2021
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
3,076 Total Patients Enrolled
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,406 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
2,260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken certain medications like tofacitinib within the past 12 weeks.You are taking more than one of the listed immunosuppressant medications, or you have changed the dosage of any of these medications within the last 12 weeks.You have received certain medications like infliximab, certolizumab, golimumab, adalimumab, abatacept, or tocilizumab within the 10 weeks before screening.You have had HIV in the past.You had a heart attack within the last 26 weeks before the screening.You have had UV phototherapy in the past 6 weeks or plan to have it during the study.You have taken strong corticosteroid medication by mouth, injection, or muscle injection in the month before screening.You have taken nintedanib within the 12 weeks before screening.You have taken afamelanotide or a similar medication that activates the MC1R receptor within 12 weeks before the screening.You have taken pirfenidone within the 12 weeks before the screening.You have taken MT 7117 before, except if you were given a placebo.You have had any other type of cancer in the last 5 years, except for cervical carcinoma in situ.You have certain types of skin cancer or suspicious skin lesions that cannot be removed through biopsy or surgery.You have been treated with Cyclophosphamide, rituximab, or cyclosporine for your SSc disease within the last 26 weeks before screening.You have a positive test for anti-centromere antibodies.You have had melanoma in the past, have family members with melanoma, or have suspicious skin lesions for melanoma.You have a history of hepatitis B or C, unless it has been successfully treated and is no longer detectable in your blood.You have taken etanercept within 4 weeks before the screening.You have a serious condition where the blood pressure in your lungs is too high, and you need to take more than one pill to treat it.You have been diagnosed with the disease for less than 5 years from when the first non-Raynaud's phenomenon symptoms appeared.You have a specific type of skin condition called diffuse cutaneous systemic sclerosis as determined by specific criteria.You have a history of certain autoimmune diseases, unless the main symptoms are related to dcSSc, as determined by the doctor.Your liver function tests show high levels of AST, ALT, ALP, or total bilirubin.You have any significant health issues not related to systemic sclerosis, as determined by the doctor during the screening.You have a lung disease and your lung function test shows less than half of what it should be.You have a significant health issue or abnormal lab results that could affect the study or your safety. This includes low levels of hemoglobin, white blood cells, or platelets.You had a kidney crisis in the last year before screening.You have a heart condition that affects the way your heart pumps blood or causes symptoms like chest pain or irregular heartbeat.You have severe chronic kidney disease with a very low estimated glomerular filtration rate (eGFR).You are at least 18 years old and have been diagnosed with systemic sclerosis using specific criteria from 2013.You have a specific level of skin involvement in certain areas of your body, including the arms, legs, and trunk.If you have had the disease for more than 24 months, you must show signs of active disease such as new skin involvement, increased skin thickness, presence of certain proteins in the blood, or abnormal blood test results.
Research Study Groups:
This trial has the following groups:- Group 1: MT-7117
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spots remaining in this clinical research protocol?
"Indeed, according to the clinicaltrials.gov website this research is open for recruitment. It was initially posted on February 5th 2021 and modified as recently as November 22nd 2022. 72 patients are needed from 16 different sites in order to complete the trial."
Answered by AI
Is the age restriction of this trial inclusive to geriatric patients?
"As indicated by the eligibility requirements, individuals aged 18 to 75 can apply for this trial. Moreover, there are 46 trials specifically targeting younger patients and 374 studies aimed at people over 65 years of age."
Answered by AI
How many healthcare facilities are utilizing this trial?
"Currently, this medical trial is being run from 16 different sites across the nation; a few examples include Los Angeles, La Jolla and Ormond Beach. To lessen travelling demands for enrolled individuals, it is wise to select the closest location possible."
Answered by AI
How many participants are currently engaged in this experiment?
"In order to successfully complete the research, 72 participants fitting the criteria must be identified. The sponsor of this trial is Mitsubishi Tanabe Pharma Development America, Inc., and they will oversee operations at UCLA Medical Center in Los Angeles and UCSD School of Medicine in La Jolla."
Answered by AI
Is this clinical trial limited to a particular subset of individuals?
"The ideal patient for this trial has a diagnosis of sclerosis and is aged between 18 to 75 years old. Up to 72 people are eligible for inclusion in the experiment."
Answered by AI
What is the current status of MT-7117 in terms of regulatory approval?
"MT-7117 received a safety score of 2, as the investigation is still in its Phase 2 stage and there are yet to be any conclusive results with regards to efficacy."
Answered by AI
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