Systemic Lupus Erythematosus study: Alnuctamab
Official title Alnuctamab for Refractory SLE (LATTE Study)
ClinicalTrials.gov ID: NCT07219563
What this study is testing
What is Alnuctamab?
An investigational once‑daily subcutaneous injection being studied for moderate to severe systemic lupus erythematosus (SLE).
Also referred to as EM901.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the drug is safe and if it might help patients with lupus that is hard to treat.
- Who it's for
- Adults with moderate to severe systemic lupus erythematosus that hasn't improved with standard treatments.
- What's involved
- Participants will receive the drug and have regular visits and tests to monitor safety and any changes in disease activity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Age 18-60 years.
- Documented diagnosis of SLE fulfilling 2019 ACR/EULAR criteria.
- Historical documentation of ANA (1:80 or greater) autoantibody on immunofluorescence as well as presence of at least 1 additional autoantibody of the...
- History of SLE that is refractory to corticosteroids and at least 2 immunosuppressive therapies with different mechanisms of action (methotrexate...
- Total SLEDAI-2K \>6 with clinical SLEDAI-2K \>4, or \>1 BILAG A organ domain score, or \>2 BILAG B, but without active central nervous system (CNS)...
You likely can't join if
- Autoimmune disease other than SLE, except associated Sjogren's Disease if not primary contributor to symptoms
- TTP-like SLE; catastrophic APS; LN WHO class V as primary qualifying criterion (unless overlap with Class III or IV), rapidly progressive LN, or eGFR...
- Active or suspected infection, including HIV.
- O2 sat \ 2X ULN (unless attributed to active myositis), Total Bilirubin \>1.5 X ULN (unless Gilbert's Disease), total B cell count \<12/microliter...
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.