Atopic DermatitisPhase 2NCT03496974
A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Bermekimab Monoclonal Antibody 200 mg and Bermekimab Monoclonal Antibody 400 mg in people with Atopic Dermatitis, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis. 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?
- Bermekimab Monoclonal Antibody 200 mg and Bermekimab Monoclonal Antibody 400 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 11 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent provided by the patient
- Age 18 years or greater
- Chronic Atopic Dermatitis present for at least 3 years
- Disease is not responsive to topical medications, or for whom topical treatments are not indicated or desired.
- Willing and able to comply with all clinic visits and study-related procedures
- EASI score ≥16 at screening and baseline visits
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- IGA score ≥3 at screening and baseline visits
- ≥10% body surface area (BSA) of AD involvement at screening and baseline visits
- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable or undesired.
Who cannot join
- Treatment with an investigational drug within 8 weeks of baseline visit
- Having received the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy for AD
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit
- Initiation of treatment during the screening period with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
Show all 18Show fewer
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies.
- Administration of any live (attenuated) vaccine within 4 weeks prior to the baseline.
- Any history of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
- Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit
- Presence of skin comorbidities that may interfere with study assessments
- Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to, patients with short life expectancy, patients with uncontrolled diabetes (HbA1c ≥ 9%), patients with cardiovascular conditions (eg, stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, case report forms [CRFs], etc.)
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- Where relevant, women unwilling to use adequate birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Academic Centers Research & Education
Coral Gables, Florida, 33134
About this study
Official title: A Phase II, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.
Read the detailed description
A Phase 2, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients with Moderate to Severe Atopic Dermatitis. The study is multi center and will consist of two dose levels:
Group A (n=9): patients will receive a total of 4 x 200mg subcutaneous injections of bermekimab. Dosing will occur weekly from visit 1 to visit 4, inclusive.
Group B (n=20): patients will receive a total of 8 x 400 mg subcutaneous injections of bermedimkb. Dosing will occur weekly from visit 1 to visit 8, inclusive.
- Conditions
- Atopic Dermatitis
- Being tested
- Bermekimab Monoclonal Antibody 200 mg, Bermekimab Monoclonal Antibody 400 mg
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bermekimab Monoclonal Antibody 200 mgDrug
200 mg subcutaneous injection
Bermekimab Monoclonal Antibody 400 mgDrug
400 mg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group A: 200 mg cohort | Experimental | The dose of bermekimab for Group A is 200 mg (2ml of the 100 mg/ml formulation) Receives: Drug: Bermekimab Monoclonal Antibody 200 mg |
| Group B: 400 mg cohort | Experimental | The dose of bermekimab for Group B is 400 mg (2ml of the 200 mg/ml formulation) administered weekly by subcutaneous injection Receives: Drug: Bermekimab Monoclonal Antibody 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.
Measured: From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.
Secondary outcomes (14)
Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)
EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively).
Group A: Change= (Baseline - Week 4 score); Group B: Change= (Baseline - Week 7 score)
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Pharmacokinetics (PK) Assessment at Week 7
An enzyme-linked immunosorbent assay (ELISA) has been developed to specifically measure bermekimab levels in human plasma. Blood will be drawn into a single 6 ml Na-Heparin collection tube at each PK collection time point. These samples will be collected per the study lab manual and immediately shipped to the Sponsor for PK analysis. The PK samples will also be used to test for the presence of antibodies against bermekimab.
PK sample collection time points are as follows:
Group A: Pre-dose at visits 1-5; visit 5 is reported Group B: Pre-dose at visit 1, visit 3, visit 5 and visit 8; visit 8 is reported
Measured: Group A: Week 4; Group B: Week 7
Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7
IGA assesses disease severity and clinical response using a 5-point scale: 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, 4 = severe. The score is determined by ranking the extent of erythema and population/infiltration. A clinical response to therapy will be an IGA score of 0 (clear) or 1 (almost clear). Patients receiving more than one treatment with additional medication for AD exacerbation during the study or who are missing IGA scores at visit 8 (week 7) will be treated as non-responders. For the 200 mg group, IGA was recorded at visits 1,3, and 5; visit 5 is reported. For the 400 mg group, IGA was recorded at visits 1-8, visit 8 was reported.
Measured: Group A: Week 4; Group B: Week 7
Number of Patients Achieving ≥2 IGA Score Reduction at Week 7
IGA assesses disease severity and clinical response using a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. The score is determined by ranking the extent of erythema and papulation/infiltration. A clinical response to therapy will be an IGA score of 0 (clear) or 1 (almost clear).
Measured: Group A: Week 4; Group B: Week 7
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7
The NRS rating system captures the intensity of patient's itch, both maximum and average intensity over a 24-hour period. The following question was presented to patients: "How would you rate your itch at the worst moment and on average during the previous 24 hours a scale of 0-10 (0=no itch and 10=worst possible itch)?
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7
The NRS rating system captures the intensity of patient's itch, both maximum and average intensity over a 24-hour period. The following question was presented to patients: "How would you rate your itch at the worst moment and on average during the previous 24 hours a scale of 0-10 (0=no itch and 10=worst possible itch)?
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7
SCORAD was developed by the European Task Force on Atopic Dermatitis. (Severity scoring of Atopic Dermatitis: the SCORAD index), as a measure of disease severity in AD. It includes assessment of the eczema in addition to patient-reported symptoms. Total score ranges from 0 to 103 (no disease to most severe disease, respectively).
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Number of Patients Achieving 50% or Greater Reduction in EASI Score at Week 7
EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively).
Measured: Group A: Week 4; Group B: Week 7
Number of Patients Achieving 50% or Greater Reduction in SCORAD Score at Week 7
Calculated as per description in Outcome 8.
Measured: Group A: Week 4; Group B: Week 7
Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.
POEM is a 7-item patient-reported quality of life outcome measure based on a questionnaire to determine disease symptoms, including bleeding, cracking, dryness, flaking, itching, sleep loss and weeping. The scoring range is from 0 to 28 (no disease to most severe disease, respectively).
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in Global Individual Signs Score (GISS) From Baseline to Week 7
GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component will be rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) according to the EASI grading severity. Total score will range from 0 to 12 (no disease to most severe disease, respectively).
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL.
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in HADS (Anxiety) Score From Baseline to Week 7
The HADS is a set of fourteen questions to be rated by a patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Scoring is as follows:
(0-7)= Normal (8-10)= Borderline Abnormal (11-21)= Abnormal
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in HADS (Depression) Score From Baseline to Week 7
The HADS is a set of fourteen questions to be rated by a patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Scoring is as follows:
(0-7)= Normal (8-10)= Borderline Abnormal (11-21)= Abnormal
Measured: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start21 May 2018
- Primary completion4 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496974
- Sponsor's protocol ID
- 2018-PT044
- Status last verified
- Feb 2021
- First submitted
- 4 Apr 2018
- Last updated
- 12 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03496974
- Acronym / sponsor ID
- 2018-PT044
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.
Detailed description
A Phase 2, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients with Moderate to Severe Atopic Dermatitis. The study is multi center and will consist of two dose levels:
Group A (n=9): patients will receive a total of 4 x 200mg subcutaneous injections of bermekimab. Dosing will occur weekly from visit 1 to visit 4, inclusive.
Group B (n=20): patients will receive a total of 8 x 400 mg subcutaneous injections of bermedimkb. Dosing will occur weekly from visit 1 to visit 8, inclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 200 mg cohort | Experimental | Drug: Bermekimab Monoclonal Antibody 200 mgThe dose of bermekimab for Group A is 200 mg (2ml of the 100 mg/ml formulation) |
| Group B: 400 mg cohort | Experimental | Drug: Bermekimab Monoclonal Antibody 400 mgThe dose of bermekimab for Group B is 400 mg (2ml of the 200 mg/ml formulation) administered weekly by subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent provided by the patient
- Age 18 years or greater
- Chronic Atopic Dermatitis present for at least 3 years
- Disease is not responsive to topical medications, or for whom topical treatments are not indicated or desired.
- Willing and able to comply with all clinic visits and study-related procedures
Key exclusion criteria (18 listed)
- Treatment with an investigational drug within 8 weeks of baseline visit
- Having received the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit
- Initiation of treatment during the screening period with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
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 |
|---|---|---|
| Bermekimab Monoclonal Antibody 200 mg200 mg subcutaneous injection | Drug | Group A: 200 mg cohort |
| Bermekimab Monoclonal Antibody 400 mg400 mg subcutaneous injection | Drug | Group B: 400 mg cohort |
Primary outcome
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.
Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.
14 secondary outcomes
Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Pharmacokinetics (PK) Assessment at Week 7
Time frame: Group A: Week 4; Group B: Week 7
Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7
Time frame: Group A: Week 4; Group B: Week 7
Number of Patients Achieving ≥2 IGA Score Reduction at Week 7
Time frame: Group A: Week 4; Group B: Week 7
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Number of Patients Achieving 50% or Greater Reduction in EASI Score at Week 7
Time frame: Group A: Week 4; Group B: Week 7
Number of Patients Achieving 50% or Greater Reduction in SCORAD Score at Week 7
Time frame: Group A: Week 4; Group B: Week 7
Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in Global Individual Signs Score (GISS) From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in HADS (Anxiety) Score From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Change in HADS (Depression) Score From Baseline to Week 7
Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bermekimab Monoclonal Antibody 200 mg and Bermekimab Monoclonal Antibody 400 mg in people with Atopic Dermatitis, run by Janssen Research & Development, LLC at 1 site 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Treatment Emergent Adverse Events (TEAEs) (time frame: From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.). 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 12 Mar 2021.