GUIDE: A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Guselkumab Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20. |
Drug: Guselkumab
Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a, 2c, 2d and 3c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
Other Names:
|
| Experimental: Part 2: Guselkumab q8w and Guselkumab q16w Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder [SRe]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score >5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16. |
Drug: Guselkumab
Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a, 2c, 2d and 3c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
Other Names:
Drug: Placebo Injection
Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.
|
| Experimental: Part 2: Guselkumab q8w Participants (Non SRe) in group 2c with a PASI score greater than (>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60. |
Drug: Guselkumab
Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a, 2c, 2d and 3c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
Other Names:
|
| Experimental: Part 3: Guselkumab Withdrawal Participants from groups 2a and 2b with a PASI score <3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 116 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to [>=] 3) at week 68 or PASI >5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w. |
Drug: Guselkumab
Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a, 2c, 2d and 3c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Group (2a and 2b): Percentage of Participants Who Achieve an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 [Week 68]
Percentage of participants who will achieve an absolute PASI Score < 3 at Week 68 will be reported. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage (%) of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Secondary Outcome Measures
- Group (1, 2a, 2b, 2c): Time to Improvement from Baseline (Week 0) in PASI Score [Baseline (Week 0) and Week 28]
Time to improvement from baseline (week 0) in PASI (PASI 75/90/100 response and absolute PASI score =0) for participants with short (less than or equal to [<=] 2 years) and longer (greater than [>] 2 years) disease duration will be reported. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75/90/100 responders are defined as participants with >= 75%, >= 90%, 100% improvement in PASI respectively from baseline at week 28.
- Group (1, 2a, 2b, 2c, 3a and 3b): Percentage of Participants Who Achieve an Absolute PASI Score of 0, <=1 and < 3 at Weeks 20, 28, 68 and 116 [Weeks 20, 28, 68 and 116]
Percentage of participants with short (<=2 years) and longer (>2 years) disease duration who achieve an absolute PASI Score of 0, <=1 and less than (<) 3 will be reported. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Each of these areas is assessed separately for erythema, induration, and scaling, which are each rated on a scale from 0 to 4. The PASI score range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Absolute PASI = 0 represents super responders with PASI score (0) at week 28.
- Group (3a and 3b): Percentage of Participants Who Retain Disease Control (Absolute PASI Score < 3) [Week 68 up to Week 116]
Percentage of participants who retain disease control (that is, absolute PASI score <3 from week 68 through week 116 for participants with short (<= 2 years) and longer (>2 years) disease duration will be reported. Control of disease is defined as participants with a PASI score <3. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
- Group (1, 2a, 2b, 2c, 3a and 3b): Percentage of Participants Who Achieve a PASI 75/90/100 response at Weeks 20, 28, 68 and 116 [Weeks 20, 28, 68 and 116]
Percentage of participants who will achieve PASI 75/90/100 response will be reported. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 responders are defined as participants with >= 75% improvement in PASI from baseline at week 28. PASI 90 responders are defined as participants with >= 90% improvement in PASI from baseline at week 28. PASI 100 responders are defined as participants with 100% improvement in PASI from baseline at week 28.
- Group (3a and 3b): Time to Loss of Disease Control (absolute PASI score >5) after Treatment Withdrawal Beyond Week 68 [Week 68 up to Week 116]
Time to loss of disease control (absolute PASI score >5) after treatment withdrawal beyond week 68 up to Week 116 will be reported. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
- Group 1: Percentage of Participants with an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28 [Weeks 12, 16, 20 and 28]
Percentage of participants with an absolute PASI score = 0 at all visits: weeks 12, 16, 20 and 28 will be reported. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
- Group (1, 2a, 2b, and 2c): Change from Baseline (Week 0) in Dermatology Life Quality Index (DLQI) score [Baseline (Week 0), Week 28 and Week 68]
Change from baseline (Week 0) in DLQI score at weeks 28 and 68 will be reported. The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a participant. Each question is scored from 0 to 3, giving a possible score range from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL).
- Group (1, 2a, 2b, and 2c): Percentage of Participants Who Achieve a DLQI Score 0/1 and <5 [Week 28 and Week 68]
Percentage of participants who achieve a DLQI score 0/1 and <5 will be reported. The DLQI is a dermatology-specific QoL instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a participant. Each question is scored from 0 to 3, summed to give a possible score range from 0 (no impact of skin disease on QoL) to 30 (maximum impact on QoL).
- Group (1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c): Percent Change from Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, and 104 [Baseline (Week 0), Weeks 12, 28, 52, 68, 80, and 104]
The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA). Percent Change from baseline in the psoriasis affected BSA (%) at weeks 12, 28, 52, 68, 80, and 104 will be reported.
- Group (1, 2a, 2b, 2c, 3a, and 3b): Change from Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68 and 116 [Baseline (Week 0), Weeks 28, 68 and 116]
Change from baseline in NAPPA-QOL at Weeks 28, 68, and 116 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-QOL is a 20-item nail-specific QoL questionnaire covering past week. Signs, stigma and everyday life are rated on a 5-point scale, ranges from 0 (no suffering) to 4 (high suffering). A global score is computed by averaging all items. A decrease in NAPPA QoL score indicates improvement.
- Group (1, 2a, 2b, 2c, 3a, and 3b): Change from Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68 and 116 [Baseline (Week 0), Weeks 28, 68 and 116]
Change from baseline in NAPPA-PBI at Weeks 28, 68, and 116 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-PBI is a 24-item questionnaire to assess participant-defined needs before and participant-rated benefits after treatment. The answers are given on a scale from 0 to 4, and a global score is calculated as follows: Each benefit item is multiplied with the respective importance item, and the product is divided by the sum of all importance items. The results are summed up over all items. The resulting global score ranges from 0 (no benefit) to 4 (highest possible benefit).
- Group (1, 2a, 2b, 2c, 3a, and 3b): Change from Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68 and 116 [Baseline (Week 0), Weeks 28, 68 and 116]
Change from baseline in NAPPA-CLIN at Weeks 28, 68, and 116 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement).
- Group (1, 2a, 2b, 2c, 3a and 3b): Change from Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68 and 116 [Baseline (Week 0), Weeks 28, 68 and 116]
Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68 and 116 will be reported. The PSSD is a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a participant self-administered outcomes instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 will be derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response). In this study, the 7-day-version of the PSSD will be used.
- Group (2a, 2b and 2c): Percentage of Participants Who Achieve a PSSD Sign Score = 0 at Week 68 in Participants with a PSSD Sign Score >= 1 at Week 28 [Week 68]
Percentage of participants who achieve a PSSD sign score = 0 at week 68 in participants with a PSSD sign score >= 1 at Week 28 will be reported. PSSD is a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a participant self-administered outcomes instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 will be derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response). In this study, the 7-day-version of the PSSD will be used.
- Group 1, 2a, 2b and 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level [Up to Week 80]
The potential association between trough serum guselkumab concentration and efficacy or serum biomarker level will be analyzed by immunoassays. For the analyses the trough serum guselkumab concentration will be set into relation with the efficacy (e.g. PASI response) or with serum biomarker (e.g. serum IL-17A, IL-17F, IL-22) concentration. Guselkumab and all biomarker concentrations will be measured in the unit of picogram/milliliter (pg/mL). In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
- Group (2a and 2b): Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI score <3 at Week 68 [Weeks 20, 28, 36, 68]
The potential association between trough serum guselkumab levels at weeks 20, 28, 36 and 68 and achieving a PASI score <3 at week 68 will be analyzed. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
- Group (2d and 3c): Percentage of Participants Who were Re-Treated due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment [Re-treatment period: Week 0 up to Week 24]
Percentage of participants who were re-treated due to loss of disease control (PASI >5) and regain control of disease (PASI <3) 24 Weeks after start of re-treatment will be reported. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
- Group (1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c): Number of participants with Adverse Events as a Measure of Safety and Tolerability [Up to Week 116]
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
- Group (1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c): Number of Participants with Clinically Significant Laboratory Abnormalities [Up to Week 116]
Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has a disease duration of plaque psoriasis of either less than or equal to (<=2) years or (greater than (>2) years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40 percent (%) participants must have a disease duration <=2 years
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Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >10 or affected body surface area (BSA) >10%) and additionally a Dermatology Life Quality Index (DLQI) score >10 at baseline (week 0)
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Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
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Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
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Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
Exclusion Criteria:
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Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab [BI-655066])
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Has received any systemic immunosuppressant (for example (e.g.) methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus), or anakinra within 4 weeks of the first administration of study drug
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Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
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Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
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Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Prive d'Antony | Antony | France | 92160 | |
| 2 | Centre Hospitalier d'Auxerre | Auxerre | France | 89011 | |
| 3 | Polyclinique Reims Bezanne - De Courlancy | Bezanne | France | 51430 | |
| 4 | Centre Hospitalier Le Mans | Le Mans | France | 72037 | |
| 5 | Hôpital Edouard Herriot | Lyon Cedex 03 | France | 69437 | |
| 6 | Le Bateau Blanc | Martigues | France | 13500 | |
| 7 | CHU Nantes | Nantes | France | 44093 | |
| 8 | CHU de Nice Hopital de l Archet | Nice | France | 06202 | |
| 9 | CHU Rouen | Rouen | France | 76000 | |
| 10 | HIA se Sainte-Anne - Toulon | Toulon | France | 83041 | |
| 11 | CHU Toulouse | Toulouse | France | 31059 | |
| 12 | Universitätsklinikum Aachen | Aachen | Germany | 52074 | |
| 13 | DermaManagement Augsburg GmbH | Augsburg | Germany | 86179 | |
| 14 | Klinikum Augsburg | Augsburg | Germany | 86179 | |
| 15 | Fachklinik Bad Bentheim | Bad Bentheim | Germany | 48455 | |
| 16 | Hautmedizin Bad Soden | Bad Soden am Taunus | Germany | 65812 | |
| 17 | Charite CCM, Dermatologie | Berlin | Germany | 10117 | |
| 18 | Vivantes Klinikum Im Friedrichshain | Berlin | Germany | 10119 | |
| 19 | Rothhaar Studien GmbH | Berlin | Germany | 10783 | |
| 20 | ISA - Interdisciplinary Study Association GmbH | Berlin | Germany | 10789 | |
| 21 | Hautarztpraxis | Berlin | Germany | 12459 | |
| 22 | Hautarztpraxis Dr.Wildfeuer | Berlin | Germany | 13055 | |
| 23 | Hautarztpraxis | Berlin | Germany | 13597 | |
| 24 | Praxis 'Haut Pur' | Berlin | Germany | 13597 | |
| 25 | Klinikum Bielefeld Rosenhoehe | Bielefeld | Germany | 33647 | |
| 26 | Katholisches Klinikum Bochum gGmbH | Bochum | Germany | 44791 | |
| 27 | Niesmann & Othlinghaus GbR | Bochum | Germany | 44793 | |
| 28 | MVZ Dermatologisches Zentrum Bonn GmbH | Bonn | Germany | 53111 | |
| 29 | Universitatsklinikum Bonn | Bonn | Germany | 53127 | |
| 30 | Hautarztpraxis | Borna | Germany | 04552 | |
| 31 | Hautarztpraxis | Bramsche | Germany | 49565 | |
| 32 | Derma Nord | Bremen | Germany | 28779 | |
| 33 | Rosenpark Research GmbH | Darmstadt | Germany | 64283 | |
| 34 | Klinikum Darmstadt GmbH - Hautklinik | Darmstadt | Germany | 64297 | |
| 35 | Klinische Forschung Dresden GmbH | Dresden | Germany | 01069 | |
| 36 | Praxis für Dermatologie und Venerologie | Dresden | Germany | 01097 | |
| 37 | University Hospital Dresden | Dresden | Germany | 01307 | |
| 38 | Pro Derma | Duelmen | Germany | 48249 | |
| 39 | Privatpraxis Dr. Hilton & Partner | Düsseldorf | Germany | 40212 | |
| 40 | Universitätsklinikum Düsseldorf | Düsseldorf | Germany | 40225 | |
| 41 | Universitaetsklinik Erlangen | Erlangen | Germany | 91054 | |
| 42 | Universitaetsklinikum Essen | Essen | Germany | 45122 | |
| 43 | Universitatsklinikum Frankfurt | Frankfurt am Main | Germany | 60590 | |
| 44 | Universitatsklinikum Freiburg | Freiburg | Germany | 79104 | |
| 45 | Derma-Study-Center Friedrichshafen GmbH | Friedrichshafen | Germany | 88045 | |
| 46 | SRH Waldklinikum Gera GmbH | Gera | Germany | 07548 | |
| 47 | Hautarztpraxis Brau/Groß | Giessen | Germany | 35390 | |
| 48 | Universitätsmedizin Göttingen | Göttingen | Germany | 37075 | |
| 49 | Universitaetsklinik Hamburg-Eppendorf | Hamburg | Germany | 20246 | |
| 50 | Klinische Forschung Hamburg | Hamburg | Germany | 20253 | |
| 51 | Dermatologikum Hamburg Gmbh | Hamburg | Germany | 20354 | |
| 52 | SCIderm GmbH | Hamburg | Germany | 20537 | |
| 53 | MensingDerma research GmbH | Hamburg | Germany | 22391 | |
| 54 | Die Hautklinik Hanau | Hanau | Germany | 63450 | |
| 55 | Haut- und Laserzentrum Heidelberg | Heidelberg | Germany | 69115 | |
| 56 | Universitätsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 57 | Hautarztpraxis Offers/Adamini | Ibbenbüren | Germany | 49477 | |
| 58 | Universitätsklinikum Jena | Jena | Germany | 07745 | |
| 59 | Universitatsklinikum Schleswig-Holstein - Kiel | Kiel | Germany | 24105 | |
| 60 | MVZ DermaKiel GmbH | Kiel | Germany | 24148 | |
| 61 | Universitaetsklinikum Koeln | Koeln | Germany | 50937 | |
| 62 | Praxis Dr. med. Beate Schwarz - Germany | Langenau | Germany | 89129 | |
| 63 | Universitätsklinikum Leipzig AÖR | Leipzig | Germany | 04103 | |
| 64 | Hautarztpraxis | Lingen | Germany | 49809 | |
| 65 | Otto Von Guericke Universität Magdeburg | Magdeburg | Germany | 39120 | |
| 66 | Gemeinschaftspraxis Scholz/Sebastian/Schilling | Mahlow | Germany | 15831 | |
| 67 | Hautarztzentrum am MDZ | Mainz | Germany | 55128 | |
| 68 | Universitaetsmedizin Mainz | Mainz | Germany | 55131 | |
| 69 | Universitatsklinikum Mannheim | Mannheim | Germany | 68167 | |
| 70 | Hautarztpraxis | Memmingen | Germany | 87700 | |
| 71 | Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR | Moenchengladbach | Germany | 41061 | |
| 72 | Technische Universitaet Muenchen | Muenchen | Germany | 80802 | |
| 73 | Universitaetsklinikum Muenster | Muenster | Germany | 48149 | |
| 74 | Klinikum Oldenburg | Oldenburg | Germany | 26133 | |
| 75 | Klinische Forschung Osnabrück | Osnabrück | Germany | 49074 | |
| 76 | Hautarztpraxis | Potsdam | Germany | 14467 | |
| 77 | Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay | Quedlinburg | Germany | 06484 | |
| 78 | Universitaetsklinikum Regensburg | Regensburg | Germany | 93053 | |
| 79 | Hautarztpraxis Mortazawi | Remscheid | Germany | 42897 | |
| 80 | Klinische Forschung Schwerin GmbH | Schwerin | Germany | 19055 | |
| 81 | Company for Medical Study & Service Selters | Selters | Germany | 56242 | |
| 82 | Hautarztpraxis Dr. Leitz & Kollegen | Stuttgart | Germany | 70178 | |
| 83 | Hautarztpraxis am Loewenmarkt | Stuttgart | Germany | 70499 | |
| 84 | Universitätsklinikum Tübingen | Tübingen | Germany | 72076 | |
| 85 | Universitätsklinikum Ulm | Ulm | Germany | 89081 | |
| 86 | Hautarztpraxis Kock | Vechta | Germany | 49377 | |
| 87 | Centrovital | Witten | Germany | 58453 | |
| 88 | HELIOS Klinikum Wuppertal GmbH | Wuppertal | Germany | 42283 | |
| 89 | CentroDerm GmbH | Wuppertal | Germany | 42287 | |
| 90 | Universitätsklinikum Würzburg | Würzburg | Germany | 97080 |
Sponsors and Collaborators
- Janssen-Cilag G.m.b.H
Investigators
- Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial, Janssen-Cilag G.m.b.H
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108514
- 2018-001238-16
- CNTO1959PSO3012