Autoimmune DisordersPhase 2SUMMITNCT07103746
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
A Phase 2 study testing Ublituximab in people with Autoimmune Disorders, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy. The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Disorders
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 Apr 2026to Aug 2029
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be able to understand and provide informed consent.
- Age 18 years or older at disease onset.
- Definite or probable IIM per the 2017 EULAR/ACR classification criteria.
- Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies:
- Anti-SRP
- Anti-HMGCR
Show all 21Show fewer
- Early disease as defined as onset of objective muscle weakness assessed by a physician and/or CK elevation attributed to IMNM within 1 year of the time of informed consent.
- Muscle weakness as assessed by an MMT-8 score < 142 of 150 and CK > 1.5x ULN along with abnormality in at least 1 of the following 4 CSMs at screening:
- PhGA ≥ 2 cm
- PtGA ≥ 2 cm
- Extramuscular global assessment ≥ 2 cm
- HAQ-DI ≥ 0.25
- Treatment with only one of the following background immunosuppressant medications for IMNM for at least 12 weeks prior to randomization and the same dose for at least 4 weeks prior to randomization:
- Methotrexate up to 25 mg weekly
- Mycophenolate mofetil up to 3000 mg daily
- Mycophenolic acid up to 2160 mg daily
- Azathioprine up to 2.5 mg/kg daily
- Tacrolimus up to 0.2 mg/kg daily
- Cyclosporine up to 5 mg/kg daily
- Current therapy consisting of glucocorticoid ≤ 20 mg/day of prednisone. The dose must be stable for at least 4 weeks prior to randomization. Participants who stopped treatment with glucocorticoids are eligible if the last dose of the glucocorticoids was at least 4 weeks before the time of informed consent.
- Female participants of childbearing potential and male participants with a partner of childbearing potential must agree to consistently and correctly use FDA approved highly effective methods of birth control, as shown in Appendix 1: Acceptable Contraception Methods for Females of Reproductive Potential, for the entire duration of the study and 6 months after last study drug infusion. Female participants of reproductive potential must have a negative pregnancy test at screening and at baseline.
Who cannot join
- End-stage myositis with end-organ involvement that poses additional risk to the participant or confounds the assessment of the participant in the study. Conditions include but are not limited to advanced symptomatic interstitial lung disease (e.g., Forced Vital Capacity (FVC) <60% and/or requiring oxygen therapy) or severe dysphagia.
- Irreversible muscle involvement and/or severe atrophy that will pose additional risk to the participant or confound the assessment of the participant in the study. This includes Muscle Damage VAS ≥ 3 cm at screening, documented history of severe atrophy of multiple muscle groups (based on MRI), and/or wheelchair bound.
- Uncontrolled interstitial lung disease or any other uncontrolled IIM manifestation that in the opinion of the investigator would be likely to require treatment with prohibited medication during the study.
- Diagnosis of other inflammatory or noninflammatory myopathies, including antibody-negative IMNM, inclusion body myositis, overlap myositis, metabolic myopathies, muscular dystrophies or family history of muscular dystrophy, drug induced, cancer-associated myositis, or endocrine-based myositis (except statin induced anti-HMGCR associated IMNM).
- Severe liver disease, such as signs of ascites or hepatic encephalopathy.
- History of malignancy (excluding non-melanoma skin cancer) unless cured by adequate treatment, with no evidence of recurrence for ≥ 5 years from the time of informed consent.
Show all 24Show fewer
- Recent or ongoing bacterial, viral, or fungal infection requiring systemic treatment within 14 days of the time of informed consent.
- Current suppressive therapy for any chronic infections including herpes simplex virus (HSV).
- Infection with Mycobacterium tuberculosis (TB) as defined by any of the following:
- Positive interferon gamma release assay (IGRA) performed at screening or within 12 weeks prior to the time of informed consent.
- Indeterminate IGRAs must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the assay remains indeterminant, a participant must have a negative purified protein derivative (PPD) skin test. Finally, if the participant has had the Bacille Calmette-Guerin (BCG) vaccine or has some other condition complicating the interpretation of TB testing, consultation with infectious disease specialist must be obtained before randomization.
- Medical history or serologic evidence at screening of chronic infections, including:
- Human immunodeficiency virus (HIV) infection b. Hepatitis B virus (HBV) as indicated by surface antigen or hepatitis B core antibody positivity c. Hepatitis C virus (HCV) as indicated by anti-hepatitis C antibody positivity. If a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if they have a negative viral load at Screening.
- Known hypersensitivity reaction to ublituximab.
- Received a live or live-attenuated vaccine < 4 weeks before the time of informed consent. Received any other type of vaccine < 2 weeks before the time of informed consent.
- Any of the following laboratory tests at screening:
- Hemoglobin < 10 g/dL b. Absolute white blood cell count < 3,000 cells/mm3 c. Platelet count < 100,000 cells/mm3 d. Absolute neutrophils < 1,500 cell/mm3 e. Peripheral B-cell < 40 cells/µL f. IgG < 690 mg/dL g. Estimated GFR < 50 mL/min/1.73 m2
- Treatment with any immunosuppressive or immunomodulatory agent, such as cyclophosphamide, biologics, and Janus kinase (JAK) inhibitors, except those listed in the inclusion criteria 7 within 12 weeks prior to randomization.
- Prior receipt of B-cell depleting agents such as rituximab, ocrelizumab, ofatumumab, or belimumab at any time.
- Treatment of IMNM with IVIG or subcutaneous immunoglobulin (SCIG) within 12 weeks of randomization, or prior receipt of more than one cycle of IVIG at any time.
- Participant has current or history (within 12 months of screening) of alcohol, drug, or medication abuse.
- Participant is pregnant or lactating or intends to become pregnant during the study.
- Use of any investigational drug within 24 weeks of the time of informed consent.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, 30322
Prateek Gandiga, MD
- Recruiting
Johns Hopkins Hospital: Division of Rheumatology
Baltimore, Maryland, 21244
Zuzana Bologna, 706-284-3630, zbologn1@jh.edu
Julie Paik, MD
- Not yet recruiting
University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology
Birmingham, Alabama, 35233
James Andrews, MD
- Recruiting
University of Chicago, Department of Medicine: Rheumatology
Chicago, Illinois, 60637
J'Heannhehbelle Rosier, 773-702-1000 ext. 21229, jrosier@bsd.uchicago.edu
Iazsmin Ventura, MD
- Not yet recruiting
Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology
Great Neck, New York, 11021
Galina Marder, MD
- Recruiting
University of Texas - Houston
Houston, Texas, 77030
Enrique Rodriguez, 713-500-4205, Enrique.Rodriguez@uth.tmc.edu
Eleni Tiniakou, MD
- Not yet recruiting
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology
Pittsburgh, Pennsylvania, 15261
Chester Oddis, MD
- Recruiting
Mayo Clinic: Division of Rheumatology
Rochester, Minnesota, 55905
Jeffery Laivell, 507-538-8095, Laivell.Jeffrey@mayo.edu
Elie Naddaf, MD
About this study
Official title: Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.
The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)
- Conditions
- Autoimmune Disorders
- Being tested
- Ublituximab, Placebo for Ublituximab
- Keywords
- Ublituximab, Active Autoantibody Positive Immune-Mediated Necrotizing Myopathy (IMNM), Idiopathic inflammatory myopathies (IIM)
- Medical subject headings
- Autoimmune Diseases, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Also called BRIUMVI(TM)
Initial dose includes 150 mg dose followed by 450 mg two weeks later; maintenance dose is 450 mg
Placebo for UblituximabDrug
0.9% sodium chloride injection
| Study group | Role | What they receive |
|---|---|---|
| Initial Ublituximab Active Group | Experimental | Receives 150 mg Ublituximab at Day 0 and 450 mg Ublituximab at Week 2, followed by 450 mgs of Ublituximab at Weeks 24 and 48.
At Week 26, will receive a Placebo dose of 450 mg to maintain the blind. Receives: Drug: Ublituximab; Drug: Placebo for Ublituximab |
| Initial Placebo of ublituximab Group | Experimental | Receives 150 mg Placebo at Day 0 and 450 mg Placebo at Week 2. Receives 150 mg Ublituximab at Week 24 followed by 450 mg Ublituximab at Weeks 26 and 48. Receives: Drug: Ublituximab; Drug: Placebo for Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the Total Improvement Score (TIS) at Week 24 reflecting the change from baseline
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology [ACR] Myositis Response Criteria/European League Against Rheumatism [EULAR]). A higher score indicates more improvement.
Measured: Baseline to Week 24
Secondary outcomes (15)
Change in mean Total Improvement Score (TIS) value
Defined as achieving the Total Improvement Score (TIS)
Measured: Baseline to weeks 48, 60, and 72
Proportion of participants achieving minimal improvement response (TIS >= 20 points)
Defined as achieving The Total Improvement Score (TIS) > =20 points (minimum improvement)
Measured: Baseline to weeks 24, 48, 60 and 72
Proportion of participants achieving moderate improvement response (TIS >= 40 points)
Defined as achieving The Total Improvement Score (TIS) > =40 points (moderate improvement)
Measured: Baseline to weeks 24, 48, 60 and 72
Median Time to achieving minimal improvement response (TIS >= 20 points)
Defined as the time to achieving The Total Improvement Score (TIS) > =20 points (minimum improvement)
Measured: Baseline to week 24
Median Time to achieving moderate improvement response (TIS >= 40 points)
Defined as the time to achieving The Total Improvement Score (TIS) > =40 points (moderate improvement)
Measured: Baseline to week 24
Proportion of participants meeting the definition of worsening
Measured: Baseline to Week 24, 48, 60, and 72
Change in muscle endurance
As measured by Functional index-3 scores (FI-3)
Measured: Baseline to Week 24, 48, 60, and 72
Change in Creatine Kinase (CK)
Measured: Baseline to Week 24, 48, 60 and 72
Change in proximal Manual Muscle Testing (MMT)
As measured by testing the following muscles: trapezius, deltoid, biceps, iliopsoas, gluteus maximum, gluteus medius, hamstrings, and quadriceps
Measured: Baseline to Week 24, 48, 60, and 72
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Day 0 to week 24
Incidence of serious adverse events (SAEs)
Measured: Day 0 to week 24
Incidence of treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
Measured: Day 0 to week 24
Change in the serum autoantibody titers
Measured: Baseline to Week 24, 48, 60 and 72
Change in peripheral B-cells
Measured: Baseline to Week 24, 48, 60 and 72
Change in cytokine levels
Measured: Baseline to Week 24, 48, 60 and 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start21 Apr 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence, TG Therapeutics, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Julie Paik, M.D., M.H.S., Study chair, Johns Hopkins Hospital: Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103746
- Sponsor's protocol ID
- DAIT AIM01
- Acronym
- SUMMIT
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2025
- Last updated
- 17 Sep 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)
- ClinicalTrials.gov ID
- NCT07103746
- Acronym / sponsor ID
- SUMMIT / DAIT AIM01
- Conditions
- Autoimmune Disorders
- Keywords
- Ublituximab, Active Autoantibody Positive Immune-Mediated Necrotizing Myopathy (IMNM), Idiopathic inflammatory myopathies (IIM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence, TG Therapeutics, Rho Federal Systems Division, Inc.
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 5 Aug 2025 (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 is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.
The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Ublituximab Active Group | Experimental | Drug: Ublituximab, Drug: Placebo for UblituximabReceives 150 mg Ublituximab at Day 0 and 450 mg Ublituximab at Week 2, followed by 450 mgs of Ublituximab at Weeks 24 and 48. At Week 26, will receive a Placebo dose of 450 mg to maintain the blind. |
| Initial Placebo of ublituximab Group | Experimental | Drug: Ublituximab, Drug: Placebo for UblituximabReceives 150 mg Placebo at Day 0 and 450 mg Placebo at Week 2. Receives 150 mg Ublituximab at Week 24 followed by 450 mg Ublituximab at Weeks 26 and 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participant must be able to understand and provide informed consent.
- Age 18 years or older at disease onset.
- Definite or probable IIM per the 2017 EULAR/ACR classification criteria.
- Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies:
- Early disease as defined as onset of objective muscle weakness assessed by a physician and/or CK elevation attributed to IMNM within 1 year of the time of informed consent.
Key exclusion criteria (24 listed)
- End-stage myositis with end-organ involvement that poses additional risk to the participant or confounds the assessment of the participant in the study. Conditions include but are not limited to advanced symptomatic interstitial lung disease (e.g., Forced Vital Capacity (FVC) <60% and/or requiring oxygen therapy) or severe dysphagia.
- Irreversible muscle involvement and/or severe atrophy that will pose additional risk to the participant or confound the assessment of the participant in the study. This includes Muscle Damage VAS ≥ 3 cm at screening, documented history of severe atrophy of multiple muscle groups (based on MRI), and/or wheelchair bound.
- Uncontrolled interstitial lung disease or any other uncontrolled IIM manifestation that in the opinion of the investigator would be likely to require treatment with prohibited medication during the study.
- Diagnosis of other inflammatory or noninflammatory myopathies, including antibody-negative IMNM, inclusion body myositis, overlap myositis, metabolic myopathies, muscular dystrophies or family history of muscular dystrophy, drug induced, cancer-associated myositis, or endocrine-based myositis (except statin induced anti-HMGCR associated IMNM).
- Severe liver disease, such as signs of ascites or hepatic encephalopathy.
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 |
|---|---|---|
| UblituximabAlso: BRIUMVI(TM)Initial dose includes 150 mg dose followed by 450 mg two weeks later; maintenance dose is 450 mg | Drug | Initial Placebo of ublituximab Group, Initial Ublituximab Active Group |
| Placebo for Ublituximab0.9% sodium chloride injection | Drug | Initial Placebo of ublituximab Group, Initial Ublituximab Active Group |
Primary outcome
The primary endpoint is the Total Improvement Score (TIS) at Week 24 reflecting the change from baseline
Time frame: Baseline to Week 24
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology [ACR] Myositis Response Criteria/European League Against Rheumatism [EULAR]). A higher score indicates more improvement.
15 secondary outcomes
Change in mean Total Improvement Score (TIS) value
Time frame: Baseline to weeks 48, 60, and 72
Proportion of participants achieving minimal improvement response (TIS >= 20 points)
Time frame: Baseline to weeks 24, 48, 60 and 72
Proportion of participants achieving moderate improvement response (TIS >= 40 points)
Time frame: Baseline to weeks 24, 48, 60 and 72
Median Time to achieving minimal improvement response (TIS >= 20 points)
Time frame: Baseline to week 24
Median Time to achieving moderate improvement response (TIS >= 40 points)
Time frame: Baseline to week 24
Proportion of participants meeting the definition of worsening
Time frame: Baseline to Week 24, 48, 60, and 72
Change in muscle endurance
Time frame: Baseline to Week 24, 48, 60, and 72
Change in Creatine Kinase (CK)
Time frame: Baseline to Week 24, 48, 60 and 72
Change in proximal Manual Muscle Testing (MMT)
Time frame: Baseline to Week 24, 48, 60, and 72
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 0 to week 24
Incidence of serious adverse events (SAEs)
Time frame: Day 0 to week 24
Incidence of treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
Time frame: Day 0 to week 24
Change in the serum autoantibody titers
Time frame: Baseline to Week 24, 48, 60 and 72
Change in peripheral B-cells
Time frame: Baseline to Week 24, 48, 60 and 72
Change in cytokine levels
Time frame: Baseline to Week 24, 48, 60 and 72
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 17 Sep 2026.
- Autoimmunity Centers of Excellence (ACE)Link provided by the sponsor.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
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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.
University of Chicago, Department of Medicine: Rheumatology
Chicago, United States
Julie Paik, M.D., M.H.S. study chair
Johns Hopkins Hospital: Division of Rheumatology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ublituximab in people with Autoimmune Disorders, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 21 inclusion and 24 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the Total Improvement Score (TIS) at Week 24 reflecting the change from baseline (time frame: Baseline to Week 24). 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 17 Sep 2026.