Back to resultsA Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Brodalumab
Fumaric acid esters
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Main Criteria for Inclusion:>
- Men or women ≥18 years of age at the time of screening.>
- Subjects with chronic plaque type psoriasis diagnosed at least 6 months before randomisation.>
- Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI >10, affected BSA >10%, and DLQI >10.>
- Subject has no known history of active tuberculosis.>
- Subject has a negative test for tuberculosis taken at screening (negative Quantiferon test).>
- Subject and/or subject's designee is/are capable of administering subcutaneous injections.>
Main Criteria for Exclusion:>
- Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.>
- Previous or current PUVA (psoralens and ultraviolet A) therapy.>
Washouts and non-permitted drugs:>
- Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or>
- Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids)>
- Have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer>
- Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer.>
Subjects with any of the following laboratory abnormalities at screening:>
- Leukocyte cell count below 3×10^9/L or lymphocyte count below 0.7×10^9/L>
- Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit)>
- Absolute neutrophil count < 2×10^9/L>
- Serum creatinine > ULN.>
- History of depressive disorder within the last 2 years including current antidepressive treatment.>
- Subjects with a history of suicidal behaviour (suicide attempt). >
- Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.>
- A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.>
Sites / Locations
- Fachklinik Bad Bentheim Klinik für Dermatologie
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum
- Rothhaar Studien GmbH Dermatologisches Studienzentrum
- Hautarztpraxis Dr. Wildfeuer
- Klinikum Bielefeld Klinik für Dermatologie und Allergologie
- Hauttumorzentrum Ruhr- Universität im St. Josef Hospital
- Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus
- Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie
- Elbe Klinikum Buxtehude Klinik für Dermatologie
- Rosenpark Research
- Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
- Universitätsklinikum Erlangen Hautklinik
- Universitätsklinikum Frankfurt Klinik für Dermatologie
- Derma-Study-Center-Friedrichshafen
- Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten
- Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen
- SCIderm GmbH
- Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie
- Universitäts-Hautklinik Heidelberg
- Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum
- Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck
- University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center
- Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie
- Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie
- Klinische Forschung Osnabrück - Klifos
- KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie
- Gemeinschaftspraxis Weber & Crainic
- Hautarztpraxis Dres. Leitz
- University Medical Center University of Tübingen
- Hautarztpraxis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brodalumab
Fumaric acid esters
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at 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.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at 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.
Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease).
Secondary Outcome Measures
Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at 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.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at 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.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Change From Baseline at Week 24 in PASI Score
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. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative change in PASI score means that the PASI score was lower at the time of data collection.
Percent Change From Baseline in PASI Score at 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. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative value in the percent change from baseline that the PASI score was lower at the time of data collection.
Change From Baseline at Week 24 in Affected Body Surface Area (BSA)
The surface area of the participant'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%).
A negative value in the percent change from baseline that the affected BSA was lower at the time of data collection.
Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1)
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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 response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
PSI Total Score of 0 at Week 24
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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 response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Number of Symptom-free Days From Randomisation to Week 24
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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 response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Burden of Symptoms
Burden of symptoms was assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment. The AUC for the PSI total score was calculated for each participant using the standard trapezoidal rule. The AUC was normalised by dividing it with the time from baseline to the last available assessment of the PSI total score.
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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.
Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score
DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life 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
DLQI consists of 10 items addressing the participant'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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03331835
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
January 24, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.>
Detailed Description
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brodalumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Fumaric acid esters
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Brodalumab
Other Intervention Name(s)
Kyntheum®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fumaric acid esters
Other Intervention Name(s)
Fumaderm®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24
Description
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.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Time Frame
Baseline to Week 24
Title
Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24
Description
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.
Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease).
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24
Description
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.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Time Frame
Baseline to Week 24
Title
Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24
Description
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.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in PASI Score
Description
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. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative change in PASI score means that the PASI score was lower at the time of data collection.
Time Frame
Baseline to Week 24
Title
Percent Change From Baseline in PASI Score at Week 24
Description
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. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative value in the percent change from baseline that the PASI score was lower at the time of data collection.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in Affected Body Surface Area (BSA)
Description
The surface area of the participant'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%).
A negative value in the percent change from baseline that the affected BSA was lower at the time of data collection.
Time Frame
Baseline to Week 24
Title
Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1)
Description
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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 response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Time Frame
Week 24
Title
PSI Total Score of 0 at Week 24
Description
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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 response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Time Frame
Week 24
Title
Number of Symptom-free Days From Randomisation to Week 24
Description
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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 response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Time Frame
Baseline to Week 24
Title
Burden of Symptoms
Description
Burden of symptoms was assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment. The AUC for the PSI total score was calculated for each participant using the standard trapezoidal rule. The AUC was normalised by dividing it with the time from baseline to the last available assessment of the PSI total score.
The PSI consists of eight psoriasis-specific questions. Trial participants rated 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.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score
Description
DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life 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.
Time Frame
Baseline to Week 24
Title
DLQI Total Score of 0 or 1 at Week 24
Description
DLQI consists of 10 items addressing the participant'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.
Time Frame
Week 24
Other Pre-specified Outcome Measures:
Title
Change From Baseline at Week 24 in NAPSI Total Score
Description
The Nail Psoriasis Severity Index (NAPSI) grades nails by first dividing the nail area with imaginary horizontal and vertical lines into 4 quarters. The following 8 clinical features of nail psoriasis are then scored based on the number of quarters in which the feature is present (0 to 4) to arrive at a NAPSI score of 0 to 32 for each nail:
Pitting.
Leukonychia.
Red spots in lunula.
Nail plate crumbling.
Oil drop (salmon patch) discoloration.
Onycholysis.
Nail bed hyperkeratosis.
Splinter haemorrhages.
A negative change in NAPSI score means that the NAPSI score was lower at the time of data collection.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Criteria for Inclusion:>
Men or women ≥18 years of age at the time of screening.>
Subjects with chronic plaque type psoriasis diagnosed at least 6 months before randomisation.>
Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI >10, affected BSA >10%, and DLQI >10.>
Subject has no known history of active tuberculosis.>
Subject has a negative test for tuberculosis taken at screening (negative Quantiferon test).>
Subject and/or subject's designee is/are capable of administering subcutaneous injections.>
Main Criteria for Exclusion:>
Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.>
Previous or current PUVA (psoralens and ultraviolet A) therapy.>
Washouts and non-permitted drugs:>
Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or>
Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids)>
Have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer>
Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer.>
Subjects with any of the following laboratory abnormalities at screening:>
Leukocyte cell count below 3×10^9/L or lymphocyte count below 0.7×10^9/L>
Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit)>
Absolute neutrophil count < 2×10^9/L>
Serum creatinine > ULN.>
History of depressive disorder within the last 2 years including current antidepressive treatment.>
Subjects with a history of suicidal behaviour (suicide attempt). >
Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.>
A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.>
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Fachklinik Bad Bentheim Klinik für Dermatologie
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rothhaar Studien GmbH Dermatologisches Studienzentrum
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Hautarztpraxis Dr. Wildfeuer
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Klinikum Bielefeld Klinik für Dermatologie und Allergologie
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Hauttumorzentrum Ruhr- Universität im St. Josef Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Elbe Klinikum Buxtehude Klinik für Dermatologie
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Rosenpark Research
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen Hautklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Frankfurt Klinik für Dermatologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Derma-Study-Center-Friedrichshafen
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten
City
Gelsenkirchen
ZIP/Postal Code
45883
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
SCIderm GmbH
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitäts-Hautklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie
City
München
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klinische Forschung Osnabrück - Klifos
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Gemeinschaftspraxis Weber & Crainic
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Hautarztpraxis Dres. Leitz
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
University Medical Center University of Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hautarztpraxis
City
Witten
ZIP/Postal Code
58453
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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
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