NCT07103746 (SUMMIT) is a Phase 2 clinical trial of Ublituximab in Autoimmune Disorders, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT07103746?

NCT07103746 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT07103746?

Interventions in NCT07103746: Ublituximab, Placebo for Ublituximab.

What condition does NCT07103746 study?

NCT07103746 studies Autoimmune Disorders.

Is NCT07103746 still recruiting?

NCT07103746 is currently recruiting now. Last updated 7 April 2026.

Last reviewed 2026-04-07 · How we verify

NCT07103746: SUMMIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)

Recruiting now Phase 2 Last updated 7 April 2026

What this trial tests

Phase 2 trial testing Ublituximab in Autoimmune Disorders in 30 participants. Currently enrolling.

Timeline

26 February 2026

Primary endpoint
1 August 2028

1 August 2029

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	26 February 2026
Primary completion	1 August 2028
Estimated completion	1 August 2029
Sites	8 locations across United States

Drugs / interventions tested

Ublituximab — full drug profile →
Placebo for Ublituximab — full drug profile →

Conditions studied

Autoimmune Disorders — all drugs for Autoimmune Disorders →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with Autoimmune Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ublituximab

Trials testing the same drug.

NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis · Phase 2, PHASE3 · not yet recruiting
NCT06864936 — Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis · NA · not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection · Phase 2 · not yet recruiting
NCT07225361 — Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis · Phase 4 · recruiting
NCT06629428 — Effects of Ublituximab on Motor Functions in Multiple Sclerosis · EARLY_PHASE1 · recruiting

Other recruiting trials for Autoimmune Disorders

Currently open trials in the same condition.

NCT06434363 — Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Di · Phase 1, PHASE2 · recruiting
NCT02972801 — Testicular Tissue Cryopreservation for Fertility Preservation · NA · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07103746 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 7 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07103746.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing