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Monoclonal Antibodies

Efgartigimod SC for Myositis (ALKIVIA+ Trial)

Phase 3

Recruiting

Research Sponsored by argenx

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 up to 60 weeks

Awards & highlights

ALKIVIA+ Trial Summary

This trial tests a drug to treat IIM with long-term safety & tolerability. It may also measure efficacy & is for adults who took ARGX-113-2007.

Who is the study for?

This trial is for adults with active Idiopathic Inflammatory Myopathy (IIM) who completed the ARGX-113-2007 study. Participants must be able to consent, follow the study plan, and use contraception if of childbearing potential. Exclusions include planned major surgery, new medical conditions that risk safety or skew results, known drug hypersensitivity, any cancer except basal cell skin carcinoma, or previous discontinuation from the related trial.Check my eligibility

What is being tested?

The trial tests long-term safety and effectiveness of a subcutaneous injection called efgartigimod PH20 SC in those with IIM. It's for people who've had it before in an earlier phase of research and looks at how well they tolerate it over time as well as its ongoing benefits.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to efgartigimod PH20 SC based on their history with the treatment in the prior ARGX-113-2007 study.

ALKIVIA+ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence treatment-emergent adverse events and adverse event of special interest

Secondary outcome measures

Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)

Individual core set measures (CSMs) of the TIS

Percentage of participants with clinically inactive disease

+5 more

ALKIVIA+ Trial Design

1Treatment groups

Experimental Treatment

Group I: EFG PH20 SCExperimental Treatment1 Intervention

participants receiving efgartigimod PH20 SC on top of background treatment

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

argenxLead Sponsor

60 Previous Clinical Trials

9,015 Total Patients Enrolled

1 Trials studying Dermatomyositis

80 Patients Enrolled for Dermatomyositis

Frequently Asked Questions

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

Is this research project currently seeking out participants?

"Current data on clinicaltrials.gov shows that this experiment is actively recruiting participants, with the post date being September 12th 2023 and the last edit taking place October 2nd 2023."

Answered by AI

What adverse effects have been attributed to regular use of EFG PH20 SC?

"The safety rating of EFG PH20 SC was assessed as a 3 due to the evidence that has been collected from previous trials and subsequent testing."

Answered by AI

At how many sites can one access this trial?

"This clinical trial has 12 active locations, ranging from the United States to Europe and beyond. For example, Houston hosts Investigator site US0010161, Alicante is home to ES0340047 ,and BG3590019 can be found in Plovdiv."

Answered by AI

What is the current capacity of participants for this investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively seeking enrolment as of the 2nd October 2023 and was first shared on 12th September 2023. There are a total of 240 individuals needed for the study at 12 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

2023. "A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05979441.

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