Safety and Preliminary Clinical Activity of Itolizumab in ARDS

NCT05978544 | Unknown Phase 1

• 1 other identifier: BPL-ITO-ARDS-1001
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with acute respiratory distress syndrome (ARDS) caused by Infectious Pneumonia.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0

  Study Day 58

Secondary Outcomes (21)

• Maximum serum concentration of Itolizumab, Cmax

  Study Day 30

• Minimum serum concentration of Itolizumab, Cmin

  Study Day 30

• Time to maximum serum concentration of Itolizumab, Tmax

  Study Day 30

• Total Itolizumab exposure across time, AUC0-t

  Study Day 30

• Half life of Itolizumab, t1/2

  Study Day 30

Study Arms (3)

Itolizumab Dose Level 1

EXPERIMENTAL

Itolizumab of 50 mg administered by intravenous infusion for once, investigator discretion to continue with the same dose every 3 days up to 7 days.

Drug: Itolizumab

Itolizumab Dose Level 2

EXPERIMENTAL

Itolizumab of 100 mg administered by intravenous infusion for once, investigator discretion to continue with the same dose every 3 days up to 7 days.

Drug: Itolizumab

Itolizumab Dose Level 3

EXPERIMENTAL

Itolizumab of 150 mg administered by intravenous infusion for once, investigator discretion to continue with the same dose every 3 days up to 7 days.

Drug: Itolizumab

Interventions

Itolizumab DRUG

Patients to be treated with Itolizumab.

Also known as: T1h

Itolizumab Dose Level 1; Itolizumab Dose Level 2; Itolizumab Dose Level 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject aged 18-75 years old (inclusive)
• Clinical diagnosis with infectious pneumonia as determined by the investigator
• Subject who havd received anti-infective treatment according to clinical practice.
• Diagnosis with ARDS according to the following criteria: (i) Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules; (ii) respiratory failure not fully explained by cardiac failure or fluid overload; (iii) Oxygenation (PaO2/FiO2) ≤300.
• ARDS diagnosed within 48 hours before administration, and fullfil the criteria of ARDS before administration
• Fullfill at least 2 of the following 4 criteria: ① elevated hs-CRP (\>6 ULN); ② elevated IL-6 (\>3 ULN); ③ high serum ferritin (\>500µg/L at any one time or more than 2-fold increase within 48 hours of onset); ④ high D-dimer (\>3 ULN).
• Negative result of serum HCG within 72 hours before enrollment for female with potential fertility
• Participant or his/her legal representive (when the participant is not capable of giving consent) is able to understand and comply with the planned procedure as required by the protocol, and sign a written informed consent form (ICF)

You may not qualify if:

• ARDS caused by non-infectious pneumonia (e.g., burns, drowning, poisoning, etc.)
• Subject who has cardiogenic pulmonary edema, and it is the main cause of respiratory failure
• Subject who is at high risk of death within 24 hours regardless of the treatment measures given as determined by the investigator
• Subject who is receiving extracorporeal membrane pulmonary oxygenation (ECMO) therapy at the time of screening.
• Subject who had received mechanical ventilation for more than 72 hours prior to administration.
• Subject with active tumors (other than carcinoma in situ or basal cell carcinoma) that requiring treatment.
• Any of the following chronic organ damage or immunosuppression:
• Cardiac: cardiac arrest within 7 days prior to screening; New York Heart Association cardiac function class IV at screening;
• Pulmonary: oxygen therapy or ventilator-dependent therapy for more than 1 month cumulatively within 6 months prior to screening; pulmonary embolism within 4 weeks prior to screening; pulmonary hypertension, end-stage lung disease, or interstitial lung disease requiring glucocorticoid therapy at screening;
• Renal: serum creatinine \> 1.5 ULN or creatinine clearance \< 30 mL/min at screening (Cockcroft-Gault formula, see study protocol annex 5 for details) or on long-term dialysis treatment;
• Liver: liver function classification of Child-Pugh grade C at screening;
• Immunosuppression status: with lymphoma, leukemia or acquired immunodeficiency; having received antitumor chemotherapy in the last 3 months, or being treated with immunosuppression for organ transplantation or immune disorders; having had allogeneic bone marrow transplantation or allogeneic hematopoietic stem cell transplantation.
• Subject who had vaccination within 28 days prior to administration, or plan to get the vaccine during the study period
• Any of the following abnormalities at screening
• Hepatitis B-related tests: ① positive for hepatitis B surface antigen (HBsAg); ② positive for hepatitis B core antibody (HBcAb); ③ positive for hepatitis B surface antibody (HBsAb) and no history of hepatitis B vaccination; ④ positive for hepatitis B e antigen or hepatitis B e antibody;

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Bin Du

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Huadong Zhu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DANDAN Gao

CONTACT

010-51571020; gaodandan@biotechplc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 7, 2023
• Study Start: December 31, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share