Acute Respiratory Distress SyndromePhase 2NCT03017547
A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome
A Phase 2 study testing IC14 in people with Acute Respiratory Distress Syndrome, run by Implicit Bioscience.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- IC14
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2020
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU admission
- Age 18-70 years
- Presence of a known ARDS clinical risk within 7 days of onset:
- Pneumonia
- Sepsis
- Trauma
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- Aspiration
- Pancreatitis
- Presence of ARDS (per Berlin criteria) defined as follows:
- Acute onset (<48 hours)
- PaO2/FiO2<300 on PEEP≥5
- Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.
- Requirement for positive pressure ventilation via endotracheal tube
- Anticipated duration of mechanical ventilation >48 hrs
Who cannot join
- Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
- Intubation for cardiopulmonary arrest
- Do-not-attempt resuscitation (DNAR) status
- Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
- Anticipated survival <48 hours from intubation
- Anticipated survival <28 days due to pre-existing medical condition
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- Significant pre-existing organ dysfunction
- Lung: Currently receiving home oxygen therapy as documented in medical record
- Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record
- Renal: Chronic renal failure requiring renal replacement therapy
- Liver: Severe chronic liver disease defined as Child-Pugh Class C
- Pre-existing, ongoing immunosuppression
- Solid organ transplant recipient
- Chronic high-dose corticosteroids (equivalent to >20 mg/prednisone/day for >14 days in the last 30 days)
- Oncolytic drug therapy within the past 14 days
- Known HIV positive with CD4 count <200 cells/mm3
- Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept)
- Pregnancy
- History of hypersensitivity or idiosyncratic reaction to IC14
- Deprivation of freedom by administrative or court order
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.
Read the detailed description
Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- IC14, Placebo
- 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.
IC14Drug
Also called monoclonal antibody against CD14
Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS
PlaceboOther
sterile normal saline for infusion
| Study group | Role | What they receive |
|---|---|---|
| IC14 | Experimental | IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4. Receives: Drug: IC14 |
| Placebo | Placebo comparator | Placebo IV once daily on Study Day 1-4 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Treatment-emergent adverse events
Measured: 28 days
Ventilator-free days
The number of days alive and free of mechanical ventilation through Day 28.
Measured: 28 days
Secondary outcomes (1)
Change in ARDS biologic markers.
- Change in plasma IL-8, sTNFR1, IL-6 from Day 0 to Day 4
- Change in alveolar neutrophils and total protein from Day 0 to Day 4
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJun 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: withdrawn, not enrolling
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implicit Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Agosti, MD, Study director, Implicit Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017547
- Sponsor's protocol ID
- AACTT01
- Status last verified
- May 2018
- First submitted
- 9 Jan 2017
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03017547
- Acronym / sponsor ID
- AACTT01
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn, not enrolling
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Implicit BioscienceIndustry (pharma, biotech, devices)
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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.
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.
Detailed description
Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC14 | Experimental | Drug: IC14IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo IV once daily on Study Day 1-4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ICU admission
- Age 18-70 years
- Presence of a known ARDS clinical risk within 7 days of onset:
- Presence of ARDS (per Berlin criteria) defined as follows:
- Anticipated duration of mechanical ventilation >48 hrs
Key exclusion criteria (20 listed)
- Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
- Intubation for cardiopulmonary arrest
- Do-not-attempt resuscitation (DNAR) status
- Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
- Anticipated survival <48 hours from intubation
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 |
|---|---|---|
| IC14Also: monoclonal antibody against CD14Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS | Drug | IC14 |
| Placebosterile normal saline for infusion | Other | Placebo |
Primary outcome
Safety
Time frame: 28 days
Treatment-emergent adverse events
Ventilator-free days
Time frame: 28 days
The number of days alive and free of mechanical ventilation through Day 28.
1 secondary outcome
Change in ARDS biologic markers.
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
Jan Agosti, MD study director
Implicit Bioscience
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IC14 in people with Acute Respiratory Distress Syndrome, run by Implicit Bioscience.
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 14 inclusion and 20 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: withdrawn, as of the sponsor's last update on 5 May 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 days). The study lists 2 primary outcomes in all. 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 5 May 2026.