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ONO-6950

Phase 2

Asthma | Small molecule | Respiratory |BrainsWay Ltd.|Last Updated: Apr 30, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

ONO-6950 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT01551147A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With AsthmaAsthma
COMPLETED25 Analytics
PHASE2COMPLETED
A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Late Asthmatic Response (3-7 hours after allergen challenge) as measured by the AUC in FEV1
Day 7
Early Asthmatic Response as measured by the AUC in FEV1
Day 7
Late Asthmatic Response as measured by the Maximum Fall in FEV1
Day 7
Early Asthmatic Response as measured by the Maximum Fall in FEV1
Day 7
Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations
At protocol-specified timepoints before and after study drug administration up to 21 days

Secondary Endpoints

Differences in PC20 pre-post treatment as measured by methacholine challenge
Day 6
Differences in PC20 pre-post allergen challenge as measured by methacholine challenge
Day 8
Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests
At protocol-specified timepoints before and after study drug administration up to 21 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental 200 mg doseEXPERIMENTAL -
Active ComparatorACTIVE_COMPARATOR -
Placebo ComparatorPLACEBO_COMPARATOR -
EEXPERIMENTALONO-6950
PPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
ONO-6950DRUG200 mg QD for 8 days
PlaceboDRUGPlacebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner
MontelukastDRUG10 mg Montelukast QD for 8 days
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients of both genders, between 18 to 60 years of age, with bronchial asthma symptoms for at least 6 months * Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing * Screening allergen challenge demonstrates tha...

Countries:CanadaUnited States
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Frequently asked questions about ONO-6950

What is ONO-6950 used for?

ONO-6950 is an investigational small molecule being studied for the treatment of asthma. It has also been evaluated in healthy adult subjects to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is in clinical development and is not yet approved by regulatory authorities.

Who makes ONO-6950?

ONO-6950 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The drug is in Phase 2 clinical development for asthma and has completed a Phase 1 study in healthy volunteers.

What phase is ONO-6950 in?

ONO-6950 is in Phase 2 clinical development for asthma. It has completed a Phase 1 study in healthy adult subjects and a Phase 2 study in patients with asthma. The drug is investigational and has not been approved by the FDA or other regulatory agencies.

What clinical trials is ONO-6950 in?

ONO-6950 has been studied in two completed clinical trials. NCT01405651 was a Phase 1 study in healthy adult subjects in the United States with 24 participants. NCT01551147 was a Phase 2 placebo and active controlled study following allergen challenge in asthma patients in Canada with 25 participants.

Is ONO-6950 the same as any other drug?

ONO-6950 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being developed by BrainsWay Ltd. for the treatment of asthma.