AsthmaPhase 2NCT07301255
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
A Phase 2 study testing ENV-294 in people with Asthma, run by Enveda Therapeutics at 20 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- ENV-294
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 20 sitesUnited States
- Study dates
- 9 Jan 2026to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Able to read, understand, and sign an informed consent form before any study procedures
- Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
- Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
- Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
- Demonstrated bronchodilator reversibility
- ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline
- History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care
Who cannot join
- Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
- History of life-threatening asthma
- Other significant pulmonary disease
- Recent bronchial thermoplasty (within 2 years)
- Uncontrolled current or recurrent concomitant illness
- Recent use of biologic therapies for asthma (within 6 months or 5 half-lives)
Show all 10Show fewer
- Require immunosuppressive medications or frequent systemic corticosteroids
- Current smokers or former smokers with significant smoking history
- Uncontrolled hypertension
- Significant hepatic impairment
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Operations contact
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Enveda Investigative Site
Albany, Georgia, 31707
- Recruiting
Enveda Investigative Site
Birmingham, Alabama, 35209
- Recruiting
Enveda Investigative Site
Boston, Massachusetts, 02115
- Recruiting
Enveda Investigative Site
Clackamas, Oregon, 97015
- Recruiting
Enveda Investigative Site
Colorado Springs, Colorado, 80907
- Recruiting
Enveda Investigative Site
Hialeah, Florida, 33012
- Recruiting
Enveda Investigative Site
Kansas City, Kansas, 66160
- Recruiting
Enveda Investigative Site
Los Angeles, California, 90025
- Recruiting
Enveda Investigative Site
Madison, Wisconsin, 53792
- Recruiting
Enveda Investigative Site
Maryville, Illinois, 62062
- Recruiting
Enveda Investigative Site
McKinney, Texas, 75069
- Recruiting
Enveda Investigative Site
Medford, Oregon, 97504
- Recruiting
Enveda Investigative Site
Miami, Florida, 33135
- Recruiting
Enveda Investigative Site
North Charleston, South Carolina, 29406
- Recruiting
Enveda Investigative Site
Owensboro, Kentucky, 42301
- Recruiting
Enveda Investigative Site
San Jose, California, 95117
- Recruiting
Enveda Investigative Site
Southfield, Michigan, 48075
- Recruiting
Enveda Investigative Site
St Louis, Missouri, 63141
- Recruiting
Enveda Investigative Site
The Bronx, New York, 10455
- Recruiting
Enveda Investigative Site
West Hills, California, 91307
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Asthma
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA).
Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.
- Conditions
- Asthma
- Being tested
- ENV-294, Placebo
- Keywords
- Asthma in Adults
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENV-294Drug
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
PlaceboDrug
Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
| Study group | Role | What they receive |
|---|---|---|
| ENV-294 Treatment Arm | Experimental | ENV-294 will be administered to those participants randomized to the treatment arm. Receives: Drug: ENV-294 |
| Placebo Arm | Placebo comparator | A placebo will be administered to those participants randomized to the placebo arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
Measured: From first dose through approximately 16 weeks
Secondary outcomes (6)
Loss of Asthma Control Events
Number and percentage of participants experiencing a loss of asthma control (LOAC) event during the treatment period, defined according to protocol-specified criteria
Measured: Baseline to Week 12
Time to Loss of Asthma Control
Time from the first dose of study drug to the first occurrence of a loss of asthma control (LOAC) event, as defined in the protocol.
Measured: Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁), measured using standardized spirometry.
Measured: Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Change from Baseline in the Asthma Control Questionnaire (ACQ-5)
Measured: Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Change from Baseline in the Asthma Quality of Life Questionnaire (AQLQ)
Measured: Baseline to Week 12
Plasma concentration of ENV-294
Plasma concentrations of ENV-294 will be measured at specified time points following oral administration of the investigational drug.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start9 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enveda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gurpreet Ahluwalia, PhD, Study director, Enveda Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301255
- Sponsor's protocol ID
- ENV-294-211
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Asthma
- ClinicalTrials.gov ID
- NCT07301255
- Acronym / sponsor ID
- ENV-294-211
- Conditions
- Asthma
- Keywords
- Asthma in Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Enveda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 2025 (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.
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA).
Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENV-294 Treatment Arm | Experimental | Drug: ENV-294ENV-294 will be administered to those participants randomized to the treatment arm. |
| Placebo Arm | Placebo comparator | Drug: PlaceboA placebo will be administered to those participants randomized to the placebo arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to read, understand, and sign an informed consent form before any study procedures
- Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
- Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
- Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
- Demonstrated bronchodilator reversibility
Key exclusion criteria (10 listed)
- Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
- History of life-threatening asthma
- Other significant pulmonary disease
- Recent bronchial thermoplasty (within 2 years)
- Uncontrolled current or recurrent concomitant illness
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 |
|---|---|---|
| ENV-294ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks. | Drug | ENV-294 Treatment Arm |
| PlaceboMatching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product. | Drug | Placebo Arm |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: From first dose through approximately 16 weeks
Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
6 secondary outcomes
Loss of Asthma Control Events
Time frame: Baseline to Week 12
Time to Loss of Asthma Control
Time frame: Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Time frame: Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Time frame: Baseline to Week 12
To assess the efficacy of ENV-294 in participants with asthma
Time frame: Baseline to Week 12
Plasma concentration of ENV-294
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.
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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.
Clinical Operations contact
Gurpreet Ahluwalia, PhD study director
Enveda Therapeutics, Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENV-294 in people with Asthma, run by Enveda Therapeutics at 20 sites in United States.
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (env-294.clinicaltrials@enveda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (time frame: From first dose through approximately 16 weeks). 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 24 Sep 2026.