A Phase 2 Study of MR11A8 in the Treatment of Patients with Moderate to Severe Acute Respiratory Distress Syndrome (MR11A8-1).

A Phase 2 Study to Conduct Preliminary Evaluations of Safety, Pharmacodynamics and Efficacy by Intravenous Administration of MR11A8 in the Treatment of Patients with Moderate to Severe Acute Respiratory Distress Syndrome(MR11A8-1).

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222665

Enrollment

Registered

2014-11-25

Start date

2014-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

investigational material(s) Generic name etc : Recombinant Human Interferon beta-1a (MR11A8) INN of investigational material : Interferon beta-1a Therapeutic category code : 229 Other agents affecting

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Be a male or female Japanese patient with a diagnosis of moderate or severe acute respiratory distress syndrome (ARDS) according to the Berlin definition of ARDS. a. Have acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms b. Have respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload c. Have bilateral opacities on chest x-ray or on computer tomography scan d. Have hypoxaemia Moderate ARDS: PaO2/FIO2=5cmH2O Severe ARDS: PaO2/FIO2=5cmH2O 2. The radiological and hypoxaemia ARDS criteria (c and d) must occur within the same 24-hour period. The time of onset of ARDS is when the last ARDS criterion is met. 3. Patients must be administered the first dose of study medication within 48 hours of fulfilling the above inclusion criteria. 4. Be intubated and mechanically ventilated. 5. Have no clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates. 6. Have provided signed written informed consent from the patient or the patient's personal legal representative.

Exclusion criteria

Exclusion criteria: 1. Be a woman known to be pregnant, lactating or having a positive or indeterminate pregnancy test 2. Take part in another pharmacotherapy protocol (simultaneously) 3. The patient is not expected to survive 24 hours. 4. Have an underlying clinical condition (e.g. brain injury GCS=30% total body surface

Design outcomes

Primary

Measure	Time frame
Safety(adverse events, vital signs, organ support, laboratory and blood gas etc.) Efficacy(mortality, ventilator free days etc.) Pharmacodynamics(MxA, CD73, inflammatory marker etc.) Safety:up to D28 Efficacy:at D28(all-cause mortarity D28 and D90) Pharmacodynamics:up to D14	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026