Atopic DermatitisPhase 1NCT06055374
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
A Phase 1 study testing BxC-I17e in people with Atopic Dermatitis, run by Brexogen Inc..
Trial summary
The purpose of this study is to assess the safety, tolerability, and efficacy of a multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BxC-I17e
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (males or females) aged 18 years or older
- Patients have documented history of moderate to severe AD, that has been present for at least 1 year
- History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
- Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit
- Willingness and ability to comply with clinic visits and study-related procedures
- Patients should be able to read, understand, and be willing to sign the ICF
Who cannot join
- Presence of any of the following laboratory abnormalities
- Hemoglobin < 11 g/dL
- WBC < 3.5 × 103/μL
- Platelet count < 125 × 103/μL
- Neutrophils < 1.75 × 103/μL
- AST/ALT > 1.5 × ULN
Show all 16Show fewer
- Total bilirubin > ULN
- Creatinine > ULN
- Creatine phosphokinase > ULN
- Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
- Active dermatologic conditions that may confound the diagnosis of AD
- Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
- Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit
- Known history of human immunodeficiency virus (HIV) infection
- Pregnant or breastfeeding women
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis
The purpose of this study is to assess the safety, tolerability, and efficacy of a multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)
- Conditions
- Atopic Dermatitis
- Being tested
- BxC-I17e, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BxC-I17eDrug
Pharmaceutical form : solution for injection
PlaceboDrug
Pharmaceutical form : solution for injection
| Study group | Role | What they receive |
|---|---|---|
| BxC-I17e | Experimental | * Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
* Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses Receives: Drug: BxC-I17e |
| Placebo | Placebo comparator | * Subcutaneous (SC) injection of the matching placebo
* Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Measured: Baseline to Week 26
Secondary outcomes (22)
Incidence, severity and relationship of adverse events(AEs)
Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
Measured: Baseline to Week 26
Number of abnormalities and change from baseline in Vital signs
Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate
Measured: Baseline to Week 26
Number of abnormalities in 12-lead electrocardiogram (ECG)
PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)
Measured: Baseline to Week 26
Number of abnormalities in clinical laboratory parameter
Hematology, clinical chemistry, and urinalysis parameters
Measured: Baseline to Week 26
Frequency and proportion of clinically significant finding of physical examination
Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic
Measured: Baseline to Week 26
Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1
The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: Baseline to Week 14
Change and percent change in Body Surface Area (BSA)
The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Measured: Baseline to Week 14
Change and percent change in Eczema Area and Severity Index (EASI)
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
Measured: Baseline to Week 14
Change and percent change in Scoring Atopic Dermatitis (SCORAD)
The SCORAD is a clinical tool for assessing the severity of Atopic dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).
Measured: Baseline to Week 14
Change and percent change in Pruritus Numerical Rating Scale (NRS)
The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable.
Measured: Baseline to Week 14
Change and percent change in Dermatology Life Quality Index (DLQI)
The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life
Measured: Baseline to Week 14
Change and percent change in Patient-Oriented Eczema Measure (POEM)
The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity.
Measured: Baseline to Week 14
Changes in the level of eosinophils in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of Thymus Activation Regulated Chemokine (TARC) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of Pulmonary Activation-Regulated Chemokine (PARC) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of eotaxin-3 in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of Macrophage-Derived Chemokine (MDC) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of periostin in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of total Immunoglobulin E (IgE) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of total Interleukin-13 (IL-13) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of total Interleukin-22 (IL-22) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Changes in the level of total Interleukin-31 (IL-31) in the serum and correlation with other parameters
The level of biomarkers in serum
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Why it stopped: This study was integrated into BRE-AD01-001 study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brexogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055374
- Sponsor's protocol ID
- BRE-AD01-002
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06055374
- Acronym / sponsor ID
- BRE-AD01-002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was integrated into BRE-AD01-001 study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brexogen Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 26 Sep 2023 (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 purpose of this study is to assess the safety, tolerability, and efficacy of a multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)
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 |
|---|---|---|
| BxC-I17e | Experimental | Drug: BxC-I17e* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses |
| Placebo | Placebo comparator | Drug: Placebo* Subcutaneous (SC) injection of the matching placebo * Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (males or females) aged 18 years or older
- Patients have documented history of moderate to severe AD, that has been present for at least 1 year
- History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
- Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit
- Willingness and ability to comply with clinic visits and study-related procedures
Key exclusion criteria (16 listed)
- Presence of any of the following laboratory abnormalities
- Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
- Active dermatologic conditions that may confound the diagnosis of AD
- Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
- Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
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 |
|---|---|---|
| BxC-I17ePharmaceutical form : solution for injection | Drug | BxC-I17e |
| PlaceboPharmaceutical form : solution for injection | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Week 26
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
22 secondary outcomes
Incidence, severity and relationship of adverse events(AEs)
Time frame: Baseline to Week 26
Number of abnormalities and change from baseline in Vital signs
Time frame: Baseline to Week 26
Number of abnormalities in 12-lead electrocardiogram (ECG)
Time frame: Baseline to Week 26
Number of abnormalities in clinical laboratory parameter
Time frame: Baseline to Week 26
Frequency and proportion of clinically significant finding of physical examination
Time frame: Baseline to Week 26
Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1
Time frame: Baseline to Week 14
Change and percent change in Body Surface Area (BSA)
Time frame: Baseline to Week 14
Change and percent change in Eczema Area and Severity Index (EASI)
Time frame: Baseline to Week 14
Change and percent change in Scoring Atopic Dermatitis (SCORAD)
Time frame: Baseline to Week 14
Change and percent change in Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline to Week 14
Change and percent change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 14
Change and percent change in Patient-Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 14
Changes in the level of eosinophils in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of Thymus Activation Regulated Chemokine (TARC) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of Pulmonary Activation-Regulated Chemokine (PARC) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of eotaxin-3 in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of Macrophage-Derived Chemokine (MDC) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of periostin in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of total Immunoglobulin E (IgE) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of total Interleukin-13 (IL-13) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of total Interleukin-22 (IL-22) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
Changes in the level of total Interleukin-31 (IL-31) in the serum and correlation with other parameters
Time frame: Baseline to Week 14
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 9 Aug 2024.
- 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 BxC-I17e in people with Atopic Dermatitis, run by Brexogen Inc..
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Aug 2024. 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 of treatment-emergent adverse events (TEAEs) (time frame: Baseline to Week 26). 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 9 Aug 2024.