Study of Aritinercept in Patients With Generalized Myasth... | NCT07596901

Studies
Study of Aritinercept in Patients With Generalized Myasthenia Gravis

NCT07596901

Sponsor

Aurinia Pharmaceuticals Inc.

Status

Recruiting

Last Update Posted

May 19, 2026Actual

Enrollment

81Estimated

Phase

Phase 1Phase 2

Conditions

Myasthenia Gravis, Generalized

Interventions

Aritinercept
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2026Actual

Primary Completion Date

Mar 2, 2029Estimated

Completion Date

Mar 2, 2029Estimated

First Submitted Date

May 13, 2026

First Submission Date that Met QC Criteria

May 13, 2026

First Posted Date

May 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aritinercept	Experimental	Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection	Drug: Aritinercept
Placebo	Placebo Comparator	Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection	Drug: Aritinercept Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aritinercept	Drug	For subcutaneous injection	Aritinercept Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events		Baseline to study completion, up to 73 weeks

Secondary Outcomes

Measure	Description	Time Frame
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score		Baseline to 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aurinia Clinical Trials Information	Contact	833-606-5975		clinicaltrials@auriniapharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aurinia Investigational Site	Recruiting	Altamonte Springs	Florida	32714	United States

Condition Browse Module

MeSH Terms

ID	Term
D009157	Myasthenia Gravis

Ancestor Terms

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided