Recent Updates
Recently added Catalysts

Tociliuzumab

Phase 2

COVID-19 Pneumonia | Monoclonal antibody | Infectious Disease |Roche Holding AG|Trials Updated: Aug 31, 2022

Tociliuzumab development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Apr 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Tociliuzumab clinical trials

Tociliuzumab · 1 trial · 1 indication

Phase 2 1
NCT04363736A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 PneumoniaCOVID-19 Pneumonia
COMPLETED97 Analytics
PHASE2COMPLETED
A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
COVID-19 Pneumonia
NCT0436373697
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)
Days 0-28. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Maximum Serum Concentration (Cmax) of Tocilizumab
Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Clearance (CL) of Tocilizumab
Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Volume of the Central Compartment (Vc) of Tocilizumab
Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ
Baseline - Day 60
Serum Concentration of Ferritin Following Administration of IV TCZ
Baseline - Day 60
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ
Baseline - Day 60
Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ
Baseline - Day 60

Secondary Endpoints

Pecentage of Participants With Adverse Events
Up to Day 60
Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time
Baseline - Day 60
Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity
Up to Day 28
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TCZ 8 mg/kgACTIVE_COMPARATORParticipants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
TCZ 4 mg/kgEXPERIMENTALParticipants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.

Interventions

NameTypeDescription
TociliuzumabDRUGParticipants will receive IV TCZ.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria * Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen \[e.g., respiratory, blood, urine, stool, and other bodily fluids\]) and evidence of pneumonia on chest X-ray or computed tomography scan * For severe patients, SpO2 ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Tociliuzumab

What is Tociliuzumab?

Tociliuzumab is an investigational monoclonal antibody developed by Roche Holding AG for the treatment of COVID-19 pneumonia. It is a Phase 2 candidate and has been studied in a single completed clinical trial. It is not yet approved for any indication.

What is Tociliuzumab used for in COVID-19 pneumonia?

Tociliuzumab is being developed for the treatment of moderate to severe COVID-19 pneumonia in adults. It is an investigational therapy and has not received regulatory approval. Its use remains limited to clinical research settings.

Who makes Tociliuzumab?

Tociliuzumab is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in COVID-19 pneumonia.

What phase is Tociliuzumab in?

Tociliuzumab is in Phase 2 clinical development. The program includes one completed Phase 2 trial. The drug is investigational and has not been approved by the FDA or any other regulatory agency for COVID-19 pneumonia or any other indication.

What clinical trials is Tociliuzumab in?

Tociliuzumab has been evaluated in one completed Phase 2 trial, NCT04363736, titled "A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia." The trial enrolled 97 adults in the United States and was active-controlled and randomized.

Explore more on BiopharmaWatch

Roche Holding AG (RHHBY)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with TCompanies A to ZEvery biotech and pharma company we track