Myasthenia Gravis, GeneralizedPhase 1/2NCT07596901
Study of Aritinercept in Patients With Generalized Myasthenia Gravis
A Phase 1/2 study testing Aritinercept in people with Myasthenia Gravis, Generalized, run by Aurinia Pharmaceuticals Inc. at 11 sites in United States.
Trial summary
This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myasthenia Gravis, Generalized
- What is being tested?
- Aritinercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Apr 2026to 2 Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-85 years old)
- Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG
- Additional inclusion criteria are defined in the protocol
Who cannot join
- Current or medical history of malignancy within the last 5 years
- Pregnant, breastfeeding or intending to become pregnant during the Study
- Additional exclusion criteria are defined in the protocol
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Aurinia Investigational Site
Altamonte Springs, Florida, 32714
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Boca Raton, Florida, 33487
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Chicago, Illinois, 60616
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Dearborn, Michigan, 48126
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Flint, Michigan, 48507
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Homestead, Florida, 33033
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Houston, Texas, 77027
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Miami, Florida, 33155
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Miami, Florida, 33173
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
O'Fallon, Illinois, 62269
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Aurinia Investigational Site
Pasadena, California, 91106
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients With Generalized Myasthenia Gravis
This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept.
- Conditions
- Myasthenia Gravis, Generalized
- Being tested
- Aritinercept, Placebo
- Keywords
- aritinercept
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AritinerceptDrug
For subcutaneous injection
PlaceboOther
For subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Aritinercept | Experimental | Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection Receives: Drug: Aritinercept |
| Placebo | Placebo comparator | Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection Receives: Drug: Aritinercept; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Measured: Baseline to study completion, up to 73 weeks
Secondary outcomes (1)
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start22 Apr 2026
- Primary completion2 Mar 2029 (estimated)
- Study completion2 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596901
- Sponsor's protocol ID
- AUR-200-2024-02
- Status last verified
- Jul 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07596901
- Acronym / sponsor ID
- AUR-200-2024-02
- Conditions
- Myasthenia Gravis, Generalized
- Keywords
- aritinercept
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 2 Mar 2029 (estimated)
- Study completion
- 2 Mar 2029 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aritinercept | Experimental | Drug: AritinerceptDouble-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection |
| Placebo | Placebo comparator | Drug: Aritinercept, Other: PlaceboDouble-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18-85 years old)
- Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG
- Additional inclusion criteria are defined in the protocol
Key exclusion criteria (3 listed)
- Current or medical history of malignancy within the last 5 years
- Pregnant, breastfeeding or intending to become pregnant during the Study
- Additional exclusion criteria are defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AritinerceptFor subcutaneous injection | Drug | Aritinercept, Placebo |
| PlaceboFor subcutaneous injection | Other | Placebo |
Primary outcome
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Time frame: Baseline to study completion, up to 73 weeks
1 secondary outcome
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score
Time frame: Baseline to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aritinercept in people with Myasthenia Gravis, Generalized, run by Aurinia Pharmaceuticals Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurinia Clinical Trials Information (833-606-5975, clinicaltrials@auriniapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events (time frame: Baseline to study completion, up to 73 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.