Acute Respiratory Distress SyndromePhase 1NCT05978544
Safety and Preliminary Clinical Activity of Itolizumab in ARDS
A Phase 1 study testing Itolizumab in people with Acute Respiratory Distress Syndrome, run by Biotech Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Itolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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;
- Positive hepatitis C virus antibody (HCV-Ab);
- Positive acquired immunodeficiency syndrome antibody (HIV-Ab).
- Subject who has a medical history of tuberculosis or those who deny a history of tuberculosis but has a positive gamma-interferon release test at screening.
- Absolute lymphocyte count < 0.2×109/L at screening
- Suspected allergic to the investigational drug or any of its excipients
- Currently pregnant, breastfeeding,or planning to become pregnant or not using reliable method to avoid pregnancy during study and within 3 months after the last study treatment
- Subject who had participated in other clinical studies (other than those not receiving interventions, such as observational study or questionnaires survey) within 3 months prior to screening, or who are participating in other experimental treatments.
- As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect the reliability of the study data.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Acute Respiratory Distress Syndrome Caused by Infectious Pneumonia
To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with acute respiratory distress syndrome (ARDS) caused by Infectious Pneumonia.
Read the detailed description
The study will enroll approximately 38 subjects in two parts:
Part 1 is an open label 3+3 single dose escalation phase. 9-24 patients with ARDS caused by infectious pneumonia across 3 dose cohorts.
Part 2 is a randomized phase and will enroll approximately 14 additional participants, randomized in a 1:1 ratio to one of the 2 doses based on efficacy data obtained from Part 1.
All participants in this study will receive Itolizumab intravenously for once, investigator discretion to continue with the same dose every 3 days up to 7 days.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Itolizumab
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItolizumabDrug
Also called T1h
Patients to be treated with Itolizumab.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Itolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study Day 58
Secondary outcomes (21)
Maximum serum concentration of Itolizumab, Cmax
Maximum serum concentration of Itolizumab
Measured: Study Day 30
Minimum serum concentration of Itolizumab, Cmin
Minimum serum concentration of Itolizumab
Measured: Study Day 30
Time to maximum serum concentration of Itolizumab, Tmax
Time to maximum serum concentration of Itolizumab
Measured: Study Day 30
Total Itolizumab exposure across time, AUC0-t
Total Itolizumab exposure across time
Measured: Study Day 30
Half life of Itolizumab, t1/2
Half life of Itolizumab
Measured: Study Day 30
Inflammatory Markers,IL-6
IL-6
Measured: Study Day 30
Inflammatory Markers,TNF-α
TNF-α
Measured: Study Day 30
Inflammatory Markers, hs-CRP
hs-CRP
Measured: Study Day 30
Inflammatory Markers,Serum ferritin
Serum ferritin
Measured: Study Day 30
Inflammatory Markers,D-dimer
D-dimer
Measured: Study Day 30
CD6 receptor expression levels
Mean change of CD6 receptor expression levels in relative to baseline
Measured: Study Day 30
T cell subsets
Mean change of different T cell subsets in relative to baseline
Measured: Study Day 30
The proportion of patients with stable or improved Lung Function
Defined as patients with stable or improved PaO2 without increasing FiO2 in relative to baseline
Measured: Study Day 30
Mean change from baseline in Murray Score
Mean change of Murray Score in relative to baseline，The higher score means the worse outcome
Measured: Study Day 30
Mean change from baseline in SOFA score
Mean change of SOFA（Sequential Organ Failure Assessment） score in relative to baseline，The higher score means the worse outcome
Measured: Study Day 30
Mechanical ventilation-free days
Duration of non-Mechanical ventilation
Measured: Study Day 30
Oxygen therapy-free days
Duration of non-Oxygen therapy
Measured: Study Day 30
Duration of ICU stay
ICU stay days
Measured: Study Day 30
Mortality rate
Defined as the proportion of patients who met fatal outcome event by Day 15 and 30
Measured: Study Day 15, 30
Clinical status assessed using a 7-category ordinal scale
Clinical status assessed using a 7-category ordinal scale
Measured: Study Day 30
Incidence of ADA
Defined as the precentage of subjects presenting anti-drug antibody
Measured: Study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start31 Dec 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Du, Principal investigator, Peking Union Medical College HospitalHuadong Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978544
- Sponsor's protocol ID
- BPL-ITO-ARDS-1001
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Acute Respiratory Distress Syndrome Caused by Infectious Pneumonia
- ClinicalTrials.gov ID
- NCT05978544
- Acronym / sponsor ID
- BPL-ITO-ARDS-1001
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with acute respiratory distress syndrome (ARDS) caused by Infectious Pneumonia.
Detailed description
The study will enroll approximately 38 subjects in two parts:
Part 1 is an open label 3+3 single dose escalation phase. 9-24 patients with ARDS caused by infectious pneumonia across 3 dose cohorts.
Part 2 is a randomized phase and will enroll approximately 14 additional participants, randomized in a 1:1 ratio to one of the 2 doses based on efficacy data obtained from Part 1.
All participants in this study will receive Itolizumab intravenously for once, investigator discretion to continue with the same dose every 3 days up to 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Itolizumab Dose Level 1 | Experimental | Drug: ItolizumabItolizumab of 50 mg administered by intravenous infusion for once, investigator discretion to continue with the same dose every 3 days up to 7 days. |
| Itolizumab Dose Level 2 | Experimental | Drug: ItolizumabItolizumab of 100 mg administered by intravenous infusion for once, investigator discretion to continue with the same dose every 3 days up to 7 days. |
| Itolizumab Dose Level 3 | Experimental | Drug: ItolizumabItolizumab of 150 mg administered by intravenous infusion for once, investigator discretion to continue with the same dose every 3 days up to 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ItolizumabAlso: T1hPatients to be treated with Itolizumab. | Drug | Itolizumab Dose Level 1, Itolizumab Dose Level 2, Itolizumab Dose Level 3 |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: Study Day 58
Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0
21 secondary outcomes
Maximum serum concentration of Itolizumab, Cmax
Time frame: Study Day 30
Minimum serum concentration of Itolizumab, Cmin
Time frame: Study Day 30
Time to maximum serum concentration of Itolizumab, Tmax
Time frame: Study Day 30
Total Itolizumab exposure across time, AUC0-t
Time frame: Study Day 30
Half life of Itolizumab, t1/2
Time frame: Study Day 30
Inflammatory Markers,IL-6
Time frame: Study Day 30
Inflammatory Markers,TNF-α
Time frame: Study Day 30
Inflammatory Markers, hs-CRP
Time frame: Study Day 30
Inflammatory Markers,Serum ferritin
Time frame: Study Day 30
Inflammatory Markers,D-dimer
Time frame: Study Day 30
CD6 receptor expression levels
Time frame: Study Day 30
T cell subsets
Time frame: Study Day 30
The proportion of patients with stable or improved Lung Function
Time frame: Study Day 30
Mean change from baseline in Murray Score
Time frame: Study Day 30
Mean change from baseline in SOFA score
Time frame: Study Day 30
Mechanical ventilation-free days
Time frame: Study Day 30
Oxygen therapy-free days
Time frame: Study Day 30
Duration of ICU stay
Time frame: Study Day 30
Mortality rate
Time frame: Study Day 15, 30
Clinical status assessed using a 7-category ordinal scale
Time frame: Study Day 30
Incidence of ADA
Time frame: Study Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Du principal investigator
Peking Union Medical College Hospital
Huadong Zhu principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Itolizumab in people with Acute Respiratory Distress Syndrome, run by Biotech Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DANDAN Gao (010-51571020, gaodandan@biotechplc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: Study Day 58). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.