A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03496974|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Bermekimab Monoclonal Antibody 200 mg Drug: Bermekimab Monoclonal Antibody 400 mg||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
|Experimental: 200 mg cohort||
Drug: Bermekimab Monoclonal Antibody 200 mg
200 mg subcutaneous injection
|Experimental: 400 mg cohort||
Drug: Bermekimab Monoclonal Antibody 400 mg
400 mg subcutaneous injection
- Incidence of Dose Limiting Toxicity [Safety and Tolerability] [ Time Frame: 8 weeks ]Dose limiting toxicity
- Change in Eczema Area and Severity Index (EASI) score, from baseline to visit 8. [ Time Frame: 8 weeks ]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).
- Patients achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Visit 8. [ Time Frame: 8 weeks ]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 will be treated as non-responders.
- Pharmacokinetics (PK) Assessment [ Time Frame: 8 weeks ]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 (sample collection is pre-dose at visit 1, visit 3, visit 5 and visit 8). 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 sued to test for the presence of antibodies against bermekimab.
- Change (%) for peak weekly averaged pruritus numerical rating scores (NRS) from baseline to week 8. [ Time Frame: 8 weeks ]The NRS rating system captures the intensity of patient's itch and pain over a 24-hour period. The following question will be 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)? and "How would your pain on average during the previous 24 hours (0=no pain and 10=severe pain)?
- Change in weekly average peak NRS from baseline to visit 8. [ Time Frame: 8 weeks ]Scoring from 0 to 10, as in outcome measure 5.
- Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to visit 8. [ Time Frame: 8 weeks ]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).
- Patients (%) achieving 50% or greater reduction in EASI Score from baseline to visit 8. [ Time Frame: 8 weeks ]Calculate as per description in Outcome 2.
- Patients (%) achieving 50% or greater reduction in SCORAD score to visit 8. [ Time Frame: 8 weeks ]Calculate as per description in Outcome 7.
- Change (%) in Patient Oriented Eczema Measure (POEM) Scores from baseline to visit 8. [ Time Frame: 8 weeks ]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).
- Changes in Global Individual Signs Score (GISS) from baseline to visit 8. [ Time Frame: 8 weeks ]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 of severity. Total score will range from 0 to 12 (no disease to most severe disease, respectively).
- Change from baseline to visit 8 in Dermatology Life Quality Index. [ Time Frame: 8 weeks ]10-item questionnaire to measure how much one's skin problem has affected one's life.
- Change from baseline to visit 8 in Hospital Anxiety and Depression Scale. [ Time Frame: 8 weeks ]14-item scale, with each question rated from 0 to 3, seven questions each applicable to anxiety and depression.
- Change (%) from pre- to post-injection, of visit 1 questionnaire for pruritus, pain and erythema. [ Time Frame: Visit 1 only. The time point which the outcome measure will be assessed will be one hour following the visit 1 injection. ]Compare pre- vs post-injection rating, at one hour post-injection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496974
|Contact: Mark Williams, MDemail@example.com|
|United States, Florida|
|Florida Academic Centers Research & Education||Recruiting|
|Coral Gables, Florida, United States, 33134|
|Contact: Fabio Azevedo 305-324-2110 ext 211 firstname.lastname@example.org|
|Contact: Ana Sosa email@example.com|