Eosinophilic EsophagitisPhase 1NCT04835168
Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
A Phase 1 study testing BT-11 low and BT-11 high in people with Eosinophilic Esophagitis, run by NImmune Biopharma.
Trial summary
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- BT-11 low and BT-11 high
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2022to 30 Jun 2022
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No patients enrolled
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- BT-11 low, BT-11 high, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-11 lowDrug
Oral
BT-11 highDrug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| BT-11 low | Experimental | Oral Receives: Drug: BT-11 low |
| BT-11 high | Experimental | Oral Receives: Drug: BT-11 high |
| Placebo | Placebo comparator | Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start30 Jan 2022 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: The closure of the study is driven by the decision to redesign the study protocol for future studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NImmune Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835168
- Sponsor's protocol ID
- BT-11-EoE
- Status last verified
- Jun 2023
- First submitted
- 10 Mar 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04835168
- Acronym / sponsor ID
- BT-11-EoE
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The closure of the study is driven by the decision to redesign the study protocol for future studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NImmune BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BT-11 low | Experimental | Drug: BT-11 lowOral |
| BT-11 high | Experimental | Drug: BT-11 highOral |
| Placebo | Placebo comparator | Drug: PlaceboOral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BT-11 lowOral | Drug | BT-11 low |
| BT-11 highOral | Drug | BT-11 high |
| PlaceboOral | Drug | Placebo |
Primary outcome
Incidence and severity of AEs
Time frame: 12 Weeks
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 7 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BT-11 low and BT-11 high in people with Eosinophilic Esophagitis, run by NImmune Biopharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Jun 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence and severity of AEs (time frame: 12 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 7 Jun 2023.