ClinicalTrials.gg
RecruitingNCT07284420Updated Sep 24, 2026

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

A Phase 2 interventional study of Efgartigimod IV and Empasiprubart IV in AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis and MG, sponsored by argenx. Recruiting at 33 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by argenx · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies testing efgartigimod alfa in Myasthenia Gravis — 11 open to participants now, 14 under way, 7 of them phase 3. efgartigimod alfa · Myasthenia Gravis.

Planned enrollment
7th of 20
70 · median 55
Started
2025
with 6 others
Phase 2
3 of 20
2 open now
Primary completion
2028-03
later than 13 of 13 live
Registered
20th of 20
by date
Lead sponsor
12 of 20
argenx

Among the 20 studies testing efgartigimod alfa in Myasthenia Gravis, this one is the 7th largest by planned enrollment, is one of 7 that started in 2025, is one of 3 in phase 2, reaches primary completion later than 13 of the 13 other live ones, and was the 20th registered.

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

Browse Myasthenia Gravis studies →

Open to participants now

11 of the 20 studies testing efgartigimod alfa in Myasthenia Gravis are open now, in 12 countries. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

About efgartigimod alfa

efgartigimod alfa: first FDA approval 2021 (VYVGART), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 104 Myasthenia Gravis studies recruiting now, 64 (62%) set no upper age limit and 23 (22%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies testing efgartigimod alfa in Myasthenia Gravis, or all of them as a file.
02

Study summary

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.

The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

More information can be found here: https://clinicaltrials.argenx.com/adaptforward1

Read the detailed description

Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV.

Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.

The study duration for each participant is approximately up to 54 weeks.

03

Conditions studied

  • AChR-Ab Seropositive Generalized Myasthenia Gravis
  • Myasthenia Gravis
  • MG
  • gMG
  • Generalized Myasthenia Gravis
  • Generalized Myasthenia Gravis (gMG)

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
  • Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
  • Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration

Exclusion criteria

Exclusion Criteria:

  • Clinical diagnosis of systemic lupus erythematosus (SLE)
  • Any known complement deficiency
  • Current administration of a complement inhibitor or received zilucoplan or eculizumab \<2 months or ravulizumab \<6 months before the first study drug administration
  • Patients proven to be to efgartigimod (ie, not achieving a improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Efgartigimod IV + Empasiprubart IV

    Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B

    Biological: Efgartigimod IV · Biological: Empasiprubart IV

  • Experimental
    Efgartigimod IV (part A + C)

    Participants not eligible for part B, receiving efgartigimod IV in part A and C

    Biological: Efgartigimod IV

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events and serious adverse events in parts A and B

    Time frame: Up to 21 weeks

Secondary outcomes

  1. MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A

    The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)

    Time frame: Up to 18 weeks

  2. Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2

    MSE: Minimal symptom expression

    Time frame: Up to 21 weeks

  3. MG-ADL total score changes from baseline over time in part B compared with part A

    The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)

    Time frame: Up to 21 weeks

  4. QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A

    The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)

    Time frame: Up to 18 weeks

  5. QMG total score changes from baseline over time in part B compared with part A

    The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)

    Time frame: Up to 21 weeks

  6. Proportion of participants who have a 50% MG ADL total score improvement in part B cycles 1 and 2

    The Myasthenia Gravis Activities of Daily Living (MG ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)

    Time frame: Up to 21 weeks

  7. Proportion of participants who have positive PASS in part B cycles 1 and 2, and part B cycles 1 or 2

    PASS: Patient acceptable symptom state

    Time frame: Up to 21 weeks

07

Study locations

33 of 33 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Mar 2028, 26 months after the start.

Of 22 phase 2 interventional studies under Myasthenia Gravis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 30. This study's planned 26 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2025
First posted
Dec 16, 2025
StartActual
Dec 19, 2025
Primary completionEst.
Mar 7, 2028
CompletionEst.
Mar 7, 2028
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07284420
Lead sponsor
argenx
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Dec 19, 2025
Primary completion
Mar 7, 2028 (estimated)
Completion
Mar 7, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Sabine Coppieters, MD
Contact
clinicaltrials@argenx.com
857-350-4834

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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