A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
|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: NCT03331835|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : May 15, 2018
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Biological: Brodalumab Drug: Fumaric acid esters||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase 4 Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||November 3, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||October 2018|
Kyntheum® (brodalumab) pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections. First 3 injections are administered weekly, and hereafter every two weeks (Q2W).
Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA).
Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis.
Other Name: Kyntheum®
Active Comparator: Fumaric acid esters
Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt) Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)
Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label.
Drug: Fumaric acid esters
Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects.
Other Name: Fumaderm®
- At least 75% improvement from baseline at Week 24 in Psoriasis Area and Severity Index (PASI) [ Time Frame: baseline to Week 24 ]The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
- Static Physician's Global Assessment (sPGA) scale score of 0 or 1 at Week 24 [ Time Frame: Week 24 ]sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation.
- At least 90% improvement from baseline at Week 24 in PASI [ Time Frame: baseline to Week 24 ]
- 100% improvement from baseline at Week 24 in PASI [ Time Frame: baseline to Week 24 ]
- Change from baseline at Week 24 in PASI score [ Time Frame: baseline to Week 24 ]
- PASI improvement (%) from baseline at Week 24 [ Time Frame: baseline to Week 24 ]
- Change from baseline at Week 24 in affected body surface area (BSA) [ Time Frame: baseline to Week 24 ]
The surface area of the subject's hand (palm and fingers) is used as a reference measurement to calculate the percentage of each body region that is affected by psoriasis. One hand is approximately equal to 1% total BSA.
Furthermore, the complete body surface area (BSA=100%) can be divided into regions that approximates percentages of BSA as follows: head and neck (10%), upper extremities (20%), the trunk including the axillae and groin (30%), and finally the lower extremities, including the buttocks (40%).
- Psoriasis Symptom Inventory (PSI) responder at Week 24 (total score ≤ 8, with no item scores > 1) [ Time Frame: Week 24 ]The PSI consists of eight psoriasis-specific questions. Subjects will be requested to rate the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms.
- PSI total score of 0 at Week 24 [ Time Frame: Week 24 ]
- Number of symptom-free days from randomisation to Week 24 (symptom-free day = daily total PSI of 0 on that day) [ Time Frame: baseline to Week 24 ]
- Burden of symptoms assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment [ Time Frame: baseline to Week 24 ]
- Change from baseline at Week 24 in Dermatology Life Quality Index (DLQI) total score [ Time Frame: baseline to Week 24 ]DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
- DLQI total score of 0 or 1 at Week 24 [ Time Frame: Week 24 ]
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): NCT03331835
|Contact: Clinical Disclosure Specialist||+45 4494 firstname.lastname@example.org|
|Fachklinik Bad Bentheim Klinik für Dermatologie||Recruiting|
|Bad Bentheim, Germany, 48455|
|Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum||Recruiting|
|Berlin, Germany, 10117|
|Rothhaar Studien GmbH Dermatologisches Studienzentrum||Recruiting|
|Berlin, Germany, 10783|
|Hautarztpraxis Dr. Wildfeuer||Recruiting|
|Berlin, Germany, 13055|
|Klinikum Bielefeld Klinik für Dermatologie und Allergologie||Recruiting|
|Bielefeld, Germany, 33647|
|Hauttumorzentrum Ruhr- Universität im St. Josef Hospital||Recruiting|
|Bochum, Germany, 44791|
|Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus||Recruiting|
|Bochum, Germany, 44793|
|Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie||Recruiting|
|Bonn, Germany, 53127|
|Elbe Klinikum Buxtehude Klinik für Dermatologie||Recruiting|
|Buxtehude, Germany, 21614|
|Darmstadt, Germany, 64283|
|Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie||Recruiting|
|Dresden, Germany, 01307|
|Universitätsklinikum Erlangen Hautklinik||Recruiting|
|Erlangen, Germany, 91054|
|Universitätsklinikum Frankfurt Klinik für Dermatologie||Recruiting|
|Frankfurt, Germany, 60590|
|Friedrichshafen, Germany, 88045|
|Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten||Recruiting|
|Gelsenkirchen, Germany, 45883|
|Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen||Recruiting|
|Hamburg, Germany, 20246|
|Hamburg, Germany, 20354|
|Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie||Recruiting|
|Hannover, Germany, 30625|
|Heidelberg, Germany, 69120|
|Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum||Recruiting|
|Kiel, Germany, 24105|
|Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck||Recruiting|
|Lübeck, Germany, 23538|
|University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center||Recruiting|
|Mainz, Germany, 55131|
|Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie||Recruiting|
|Mannheim, Germany, 68167|
|Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie||Recruiting|
|München, Germany, 80802|
|Klinische Forschung Osnabrück - Klifos||Recruiting|
|Osnabrück, Germany, 49074|
|KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie||Recruiting|
|Recklinghausen, Germany, 45657|
|Gemeinschaftspraxis Weber & Crainic||Recruiting|
|Schweinfurt, Germany, 97421|
|Hautarztpraxis Dres. Leitz||Recruiting|
|Stuttgart, Germany, 70178|
|University Medical Center University of Tübingen||Recruiting|
|Tübingen, Germany, 72076|
|Witten, Germany, 58453|
|Study Director:||Study Director||LEO Pharma|