NCT07301255 ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
| NCT ID | NCT07301255 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Enveda Therapeutics |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-01-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Require immunosuppressive medications or frequent systemic corticosteroids * Current smokers or former smokers with significant smoking history * Uncontrolled hypertension * Significant hepatic impairment
Contact & Investigator
Clinical Operations
✉ env-294.clinicaltrials@enveda.comGurpreet Ahluwalia, PhD
STUDY DIRECTOR
Enveda Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT07301255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07301255 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07301255 currently recruiting?
Yes, NCT07301255 is actively recruiting participants. Contact the research team at env-294.clinicaltrials@enveda.com for enrollment information.
Where is the NCT07301255 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, San Jose, United States, Colorado Springs, United States and 10 additional locations.
Who is sponsoring the NCT07301255 clinical trial?
NCT07301255 is sponsored by Enveda Therapeutics. The principal investigator is Gurpreet Ahluwalia, PhD at Enveda Therapeutics, Inc.. The trial plans to enroll 50 participants.
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