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Monoclonal Antibodies

Efgartigimod for Low Platelet Count (ADVANCE SC+ Trial)

Phase 3
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period
Participant has completed a 52-week treatment period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks (week 17-24)
Awards & highlights

ADVANCE SC+ Trial Summary

This trial will test the safety and effectiveness of a new drug, efgartigimod PH20, in adults with primary immune thrombocytopenia.

Who is the study for?
This trial is for adults with primary immune thrombocytopenia who completed a previous 24-week study and can commit to another 52 weeks. They must understand the trial, consent to procedures, attend visits, use contraception if applicable, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The safety and effectiveness of efgartigimod PH20 SC (a subcutaneous injection) are being tested in patients with low platelet counts due to primary immune thrombocytopenia over an additional year following a prior study.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to efgartigimod PH20 SC or its ingredients. Specific side effects are not listed but would typically relate to the body's response to new medications.

ADVANCE SC+ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed the 24-week ARGX-113-2004 trial.
Select...
I have completed a 52-week treatment period.

ADVANCE SC+ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks (week 17-24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks (week 17-24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ECG: PR, QT and QRS interval in the overall population
Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)
Laboratory safety evaluations: CRP analysis in the overall population
+1 more
Secondary outcome measures
Change from baseline in PRO (Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) at planned visits
Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue]) at planned visits
Change from baseline in PRO (QoL (Short Form-36 [SF-36]) at planned visits
+24 more

Side effects data

From 2021 Phase 3 trial • 110 Patients • NCT04735432
15%
Injection site rash
13%
Headache
13%
Injection site erythema
11%
Myasthenia gravis
9%
Injection site pruritus
7%
Injection site bruising
5%
Injection site pain
4%
Fatigue
2%
Fall
2%
Cellulitis
2%
Humerus fracture
2%
Dyspnoea
2%
Optic neuritis
2%
Syncope
2%
Diarrhoea
2%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Efgartigimod IV

ADVANCE SC+ Trial Design

1Treatment groups
Experimental Treatment
Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention
Patients receiving efgartigimod PH20 SC treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod PH20 SC
2021
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
9,097 Total Patients Enrolled

Media Library

efgartigimod PH20 SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04812925 — Phase 3
Thrombocytopenic Purpura Research Study Groups: efgartigimod PH20 SC
Thrombocytopenic Purpura Clinical Trial 2023: efgartigimod PH20 SC Highlights & Side Effects. Trial Name: NCT04812925 — Phase 3
efgartigimod PH20 SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04812925 — Phase 3

Frequently Asked Questions

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

Is this the inaugural trial for this treatment?

"Research for efgartigimod PH20 SC started in 2020 with a study conducted and sponsored by argenx. Since the first Phase 3 trial in 2020, there have been 4 active studies involving this drug across 32 cities and 39 countries."

Answered by AI

What is the most recent decision by the FDA on efgartigimod PH20 SC?

"While Phase 3 trials are not as conclusive as those in later stages, there is some evidence for efgartigimod PH20 SC's efficacy and multiple rounds of data supporting safety. As such, we've given it a score of 3."

Answered by AI

Are there any other published papers that cite efgartigimod PH20 SC?

"efgartigimod PH20 SC was first studied in 2020 at Investigator Site 3800006. As of right now, there have been a total of 11 completed studies. There are 4 clinical trials recruiting patients at the moment, with a majority of these studies taking place in Bentonville, Arkansas."

Answered by AI

Can patients still sign up for this experiment?

"This clinical trial, as reported on clinicaltrials.gov, is currently looking for candidates. The study was first posted on 11/17/2021 and was most recently updated on 6/27/2022."

Answered by AI

How many participants will be included in this clinical trial?

"In order to move forward, this clinical trial requires 156 participants that match the pre-specified inclusion criteria. Patients have the opportunity to participate at various sites, such as Investigator Site 0010116 located in Bentonville, Arkansas or Investigator Site 0010095 situated in Oklahoma City, Oklahoma."

Answered by AI
~89 spots leftby Oct 2026