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A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis (GUIDE)

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: NCT03818035
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H

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
Psoriasis Drug: Guselkumab Drug: Placebo Injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 888 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : August 28, 2022
Estimated Study Completion Date : February 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Guselkumab

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 Name: TREMFYA

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 Name: TREMFYA

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 Name: TREMFYA

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 Name: TREMFYA




Primary Outcome Measures :
  1. Group (2a and 2b): Percentage of Participants Who Achieve an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 [ Time Frame: 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 :
  1. Group (1, 2a, 2b, 2c): Time to Improvement from Baseline (Week 0) in PASI Score [ Time Frame: 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.

  2. 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 [ Time Frame: 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.

  3. Group (3a and 3b): Percentage of Participants Who Retain Disease Control (Absolute PASI Score < 3) [ Time Frame: 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.

  4. 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 [ Time Frame: 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.

  5. Group (3a and 3b): Time to Loss of Disease Control (absolute PASI score >5) after Treatment Withdrawal Beyond Week 68 [ Time Frame: 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.

  6. Group 1: Percentage of Participants with an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28 [ Time Frame: 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.

  7. Group (1, 2a, 2b, and 2c): Change from Baseline (Week 0) in Dermatology Life Quality Index (DLQI) score [ Time Frame: 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).

  8. Group (1, 2a, 2b, and 2c): Percentage of Participants Who Achieve a DLQI Score 0/1 and <5 [ Time Frame: 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).

  9. 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 [ Time Frame: 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.

  10. 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 [ Time Frame: 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.

  11. 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 [ Time Frame: 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).

  12. 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 [ Time Frame: 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).

  13. 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 [ Time Frame: 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.

  14. 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 [ Time Frame: 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.

  15. Group 1, 2a, 2b and 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level [ Time Frame: 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.

  16. 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 [ Time Frame: 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.

  17. 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 [ Time Frame: 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.

  18. Group (1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c): Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.

  19. Group (1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c): Number of Participants with Clinically Significant Laboratory Abnormalities [ Time Frame: Up to Week 116 ]
    Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) will be reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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)
  • Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
  • 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
  • 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:

  • Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab [BI-655066])
  • 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
  • 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
  • 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
  • Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug

Information from the National Library of Medicine

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): NCT03818035


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
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Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H

Additional Information:
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Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT03818035     History of Changes
Other Study ID Numbers: CR108514
2018-001238-16 ( EudraCT Number )
CNTO1959PSO3012 ( Other Identifier: Janssen-Cilag G.m.b.H, Germany )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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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
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs