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ALT-836

Phase 2

Sepsis | Small molecule | Infectious Disease |ImmunityBio, Inc.|Last Updated: Apr 10, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ALT-836 · 1 trial · 3 indications

Phase 2 1
NCT00879606Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress SyndromeSepsis
COMPLETED150 Analytics
PHASE2COMPLETED
Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
SepsisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety profile of the study drug
Throughout the 28 days following treatment
Number of ventilator-free days at Day 28
Determined at Day 28

Secondary Endpoints

Mortality at Day 7, 14, 21, 28 and 60
Determined at Day 7, 14, 21, 28 and 60
Length of hospitalization at Day 28
Determined at Day 28
Length of ICU stay at Day 28
Determined at Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALParticipants will be randomized to receive ALT-836.
2PLACEBO_COMPARATORPatients will be randomized to receive placebo.

Interventions

NameTypeDescription
ALT-836DRUGIn the first part of this study, recombinant chimeric anti-tissue factor antibody ALT-836 was administered as a single dose (0.06 mg/Kg) via intravenous infusion over 15 minutes. In the second part of this study, up to four doses (0.06 mg/Kg) of ALT-836 will be administered via intravenous infusion over 15 minutes.
PlaceboDRUGIn the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes. In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

INCLUSION CRITERIA: 1. Suspected or proven infection 2. Hypoxemia: PaO2/FiO2is ≤300 mm Hg 3. Bilateral infiltrates consistent with pulmonary edema 4. Positive-pressure mechanical ventilation through an endotracheal tube 5. No clinical evidence of left atrial hypertension to explain bilateral infilt...

Countries:United States
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Frequently asked questions about ALT-836

What is ALT-836 used for in sepsis?

ALT-836 is an investigational small molecule being studied for the treatment of sepsis, specifically in patients with acute lung injury or acute respiratory distress syndrome. It is currently in Phase 2 clinical development and has not been approved by the FDA.

What does ALT-836 target?

ALT-836 is an anti-tissue factor (TF) antibody, meaning it targets tissue factor, a protein involved in coagulation and inflammation. By blocking tissue factor, it may help reduce the harmful effects of sepsis on the lungs and other organs.

Who is developing ALT-836?

ALT-836 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with sepsis.

What phase is ALT-836 in?

ALT-836 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug, meaning it has not yet received regulatory approval for any use.

What clinical trials is ALT-836 in?

ALT-836 has been studied in one completed Phase 2 clinical trial, identified as NCT00879606. This trial enrolled 150 patients with sepsis and acute lung injury or acute respiratory distress syndrome, and it was conducted in the United States.

Is ALT-836 the same as anti-TF antibody?

Yes, ALT-836 is also known as an anti-TF antibody, which refers to its mechanism of targeting tissue factor. This name is used in clinical trial descriptions to identify the drug's action against tissue factor in sepsis patients.