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Efzofitimod for Scleroderma-Related Lung Disease
Phase 2
Recruiting
Research Sponsored by aTyr Pharma, 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 24 weeks
Awards & highlights
Study Summary
This trial will evaluate the safety and effectiveness of an experimental drug to treat SSc-ILD, with 25 participants receiving either the drug, placebo, or a different dose of the drug. Results will measure changes in skin and ILD.
Who is the study for?
This trial is for patients with a specific lung condition called SSc-ILD, linked to systemic sclerosis. Participants must have been diagnosed within the last 4 years and show significant lung involvement. They should be on a stable dose of mycophenolate and can have limited or diffuse skin disease. Smokers, those with severe lung function decline, other rheumatic diseases, or recent use of certain medications are excluded.Check my eligibility
What is being tested?
The study tests efzofitimod at two different doses (450 mg and 270 mg) against a placebo in people with SSc-ILD. It's double-blind meaning neither doctors nor participants know who gets what treatment. The main goal is to see if it improves lung disease and skin changes over time.See study design
What are the potential side effects?
While the side effects of efzofitimod in this context aren't detailed here, similar drugs often cause immune system reactions, infections due to lowered immunity, infusion-related responses like fever or chills, possible liver issues, and gastrointestinal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change from baseline in forced vital capacity (FVC) in mL
Annual rate of decline in FVC in mL
Annual rate of decline in FVC in percent predicted
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: efzofitimod 450 mgExperimental Treatment1 Intervention
Administered IV infusion
Group II: efzofitimod 270 mgExperimental Treatment1 Intervention
Administered IV infusion
Group III: PlaceboPlacebo Group1 Intervention
Administered IV infusion
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Who is running the clinical trial?
aTyr Pharma, Inc.Lead Sponsor
9 Previous Clinical Trials
453 Total Patients Enrolled
Lisa CareyStudy DirectoraTyr Pharma, Inc.
1 Previous Clinical Trials
264 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease that is not systemic sclerosis.My lung function is significantly reduced.I have high blood pressure in the lungs and am on IV medication or have signs of heart failure.I have been diagnosed with systemic sclerosis according to the 2013 criteria.I have not taken rituximab, IVIG, tocilizumab, cyclophosphamide, pirfenidone, or any tyrosine-kinase inhibitors.My condition is either limited or diffuse systemic sclerosis.I have been diagnosed with or tested positive for anti-synthetase syndrome.My scleroderma symptoms started less than 4 years ago, not counting Raynaud's.I haven't taken high doses of steroids in the last 2 weeks.My recent HRCT scan shows no other major lung issues.I am taking less than 2 grams of MMF a day for SSc-ILD or using other treatments.My recent scans show more than 10% of my lungs are affected by scleroderma.I have a lab marker for active disease or a significant decline in lung function, or I've been on MMF for 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: efzofitimod 450 mg
- Group 2: efzofitimod 270 mg
- Group 3: 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.
Is this medical experiment looking for new participants?
"This medical investigation, posted on September 1st 2023 and most recently adjusted on July 12th of the same year is not currently recruiting. Alternatively, clinicaltrials.gov has 811 other investigations that are actively seeking volunteers."
Answered by AI
What sort of safety profile does efzofitimod 450 mg possess?
"Although there is some evidence that efzofitimod 450 mg may be safe, as this trial only reached Phase 2, the safety score was set to a '2'. At the time of evaluation, data regarding efficacy had yet to be collected."
Answered by AI
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