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Monoclonal Antibodies
Efgartigimod for Myositis (ALKIVIA Trial)
Phase 2 & 3
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2: 24 weeks; phase 3: 52 weeks
Awards & highlights
ALKIVIA Trial Summary
This trial measures how well efgartigimod PH20 SC treats people with Idiopathic Inflammatory Myopathy (DM, IMNM, PM, ASyS). It'll measure improvement using Total Improvement Score (TIS).
Who is the study for?
Adults with active Idiopathic Inflammatory Myopathy (IIM), specifically dermatomyositis, immune-mediated necrotizing myopathy, or polymyositis including antisynthetase syndrome. Participants must have muscle weakness and abnormal enzyme levels indicating IIM. They should be on stable IIM treatments and use contraception if applicable. Exclusions include other primary causes of muscle weakness, severe infections like HIV/HBV/HCV, recent major surgery risks, drug abuse history, pregnancy/lactation intentions during the study period.Check my eligibility
What is being tested?
The trial is testing Efgartigimod PH20 SC's effectiveness compared to a placebo in improving symptoms of IIM as measured by Total Improvement Score (TIS). It includes adults diagnosed with certain subtypes of IIM who will receive either the investigational medication or a placebo while continuing their standard treatment for IIM.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site due to Efgartigimod PH20 SC or general side effects associated with immunotherapy such as fatigue, headache, nausea or potential allergic reactions.
ALKIVIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can legally consent and am able to sign the consent form.
Select...
I have been diagnosed with idiopathic inflammatory myopathy.
Select...
I have been diagnosed with polymyositis or antisynthetase syndrome.
Select...
I have been diagnosed with immune-mediated necrotizing myopathy.
Select...
I have been diagnosed with idiopathic inflammatory myopathy.
Select...
I have been diagnosed with DM, JDM, PM (including ASyS), or IMNM.
ALKIVIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase 2: 24 weeks; phase 3: 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2: 24 weeks; phase 3: 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total improvement score (TIS); measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Secondary outcome measures
Change in Patient Global Assessment of Disease Activity (PGA)
Change in Physician Global Assessment of Disease Activity (MDGA)
Change in manual muscle testing-8 (MMT8) score
+5 moreALKIVIA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EFG PH20 SCExperimental Treatment1 Intervention
participants receiving efgartigimod PH20 SC on top of background treatment
Group II: PBO PH20 SCPlacebo Group1 Intervention
participants receiving placebo PH20 SC on top of background treatment
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
60 Previous Clinical Trials
9,015 Total Patients Enrolled
1 Trials studying Polymyositis
240 Patients Enrolled for Polymyositis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to the experimental medication or any of its ingredients.You have another autoimmune disease that could make it difficult to accurately evaluate your symptoms of idiopathic inflammatory myopathy (IIM) or might put you at increased risk.I have taken part in an efgartigimod study and received at least one dose of the trial medication.I have a muscle condition like myositis or muscle dystrophy, not caused by drugs or hormones.I was diagnosed with dermatomyositis before I turned 18, and it was within the last 5 years.I have been diagnosed with active disease due to abnormal enzyme levels, tests, or visible symptoms.I have been diagnosed with idiopathic inflammatory myopathy.I don't have any health issues that could interfere with the study or increase my risk.I have severe kidney problems.I can legally consent and am able to sign the informed consent form.I have been diagnosed with polymyositis or antisynthetase syndrome.I do not have any serious infections currently.I had cancer but have been free of it for over 3 years, or I only had minor skin, cervical, breast, or prostate cancer.I have severe muscle damage.I have been diagnosed with immune-mediated necrotizing myopathy.I can legally consent and am able to sign the consent form.My muscle weakness is mainly due to long-term steroid use or a non-IIM cause.I have been diagnosed with idiopathic inflammatory myopathy.I experience muscle weakness.You have had problems with alcohol, drugs, or medication abuse within the last year.I have not had a live vaccine in the last 4 weeks.I do not have uncontrolled lung disease or muscle inflammation that needs treatment not allowed in the study.I am on approved treatment for my muscle inflammation disease.I was diagnosed with juvenile myositis over 5 years ago or have severe calcinosis.I have been diagnosed with DM, JDM, PM (including ASyS), or IMNM.
Research Study Groups:
This trial has the following groups:- Group 1: EFG PH20 SC
- Group 2: PBO PH20 SC
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 new participants being accepted into this clinical trial?
"The clinical trial is currently recruiting patients, with the most recent update to the study being on 10/24/2022. The posting for this trial was originally made on 10/12/2022 and it is enrolling 240 patients at 1 location."
Answered by AI
How many people total will be involved in this clinical trial?
"That is correct. The listing on clinicaltrials.gov indicates that the researchers are currently looking for participants. This trial was first posted on October 12th, 2020 and was last updated two weeks ago on October 24th, 2020. They are hoping to enroll 240 patients from a single location."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
Investigator site 02 - 0010128
What portion of applicants met pre-screening criteria?
Did not meet criteria
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