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An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02325219
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CNTO 1959 50 mg Drug: CTNO 1959 100 mg Drug: Placebo 50 mg Drug: Placebo 100 mg Phase 3

Detailed Description:
A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Actual Study Start Date : December 19, 2014
Actual Primary Completion Date : March 2, 2016
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Group 1
Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.
Drug: CNTO 1959 50 mg
Participants will receive subcutaneous injection of CNTO 1959 50 mg.
Other Name: Guselkumab

Drug: Placebo 100 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Experimental: Group 2
Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.
Drug: CTNO 1959 100 mg
Participants will receive subcutaneous injection of CNTO 1959 100 mg.
Other Name: Guselkumab

Drug: Placebo 50 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Experimental: Group 3
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
Drug: CNTO 1959 50 mg
Participants will receive subcutaneous injection of CNTO 1959 50 mg.
Other Name: Guselkumab

Drug: CTNO 1959 100 mg
Participants will receive subcutaneous injection of CNTO 1959 100 mg.
Other Name: Guselkumab

Drug: Placebo 50 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Drug: Placebo 100 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.




Primary Outcome Measures :
  1. Number of Participants who Achieve an Investigator's Global Assessment (IGA) Score of 0 or 1 [ Time Frame: Week 16 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. The total IGA score ranges from 0 to 4. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  2. Number of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response [ Time Frame: Week 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to Baseline


Secondary Outcome Measures :
  1. Number of Participants who Achieve a PASI 75 Response [ Time Frame: Week 16 and 48 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. Total PASI score ranges from 0 to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

  2. Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participants QOL. It is a 10-item questionnaire that in addition to evaluating overall QOL can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  3. Number of Participants who Achieve an Investigator's Global Assessment (IGA) score of 0 or 1 [ Time Frame: Week 48 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  4. Number of Participants who Achieve a Psoriasis Area and Severity Index (PASI 90) Response [ Time Frame: Week 48 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4.Total PASI score ranges from 0 to 72.

  5. Number of Participants who Achieve an IGA Score of Cleared (0) and Mild or Better less than or equal (<=) to 2 [ Time Frame: Week 16 and 48 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Total IGA score ranges from 0 to 4.

  6. Number of Participants who Achieve PASI 100 and PASI 50 Response [ Time Frame: Week 16 and 48 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4. PASI 100 and 50 response was defined as at least a 100 and 50% reduction in PASI relative to Baseline. Total PASI score ranges from 0 to 72.

  7. Number of Participants who Achieve a DLQI Score of 0 or 1 Among Randomized Participants with Baseline DLQI greater than (>) 1 [ Time Frame: Week 16 and 48 ]
    The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participants QOL. It is a 10-item questionnaire that in addition to evaluating overall QOL can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  8. Number of Participants with a Reduction of 5 or More Points in DLQI Score [ Time Frame: Week 16 and 48 ]
    The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participants QOL. It is a 10-item questionnaire that in addition to evaluating overall QOL can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  9. Percent Improvement From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Among Participants with Nail Psoriasis at Baseline [ Time Frame: Week 16 and 48 ]
    The NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis). The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.

  10. Number of Participants with an Scalp Specific Investigator's Global Assessment (ss-IGA) Score of Cleared (0) or Minimal (1) Among Randomized Participants with Scalp Psoriasis and an ss-IGA Score >=2 at Baseline [ Time Frame: Week 16 and 48 ]
    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: no signs (0), slight signs (1), moderate signs (2), severe signs (3), and very severe signs (4). The sum of the 3 stores results in a total sign score ranging from 0 to 12.

  11. Change From Baseline in EuroQOL Five Dimensions Questionnaire (EQ-5D) [ Time Frame: Baseline, Week 16 and 48 ]
    The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  12. Change From Baseline in the Physical and Mental Component Summary Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) [ Time Frame: Baseline, Week 16 and 48 ]
    The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception. Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.

  13. Change From Baseline in Work Productivity and Activity Impairment Questionnaire : Psoriasis (WPAI: PSO) [ Time Frame: Baseline, Week 16 and 48 ]
    The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. This instrument generates four scores between 0 and 100: absenteeism (work time missed), presenteeism (impairment at work / reduced productivity while working), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment, which were expressed in percentage of impairment.

  14. American College of Rheumatology (ACR) 20 Response for Participants who had a Diagnosis of Psoriatic Arthritis (PsA) at Screening [ Time Frame: Week 48 ]
    ACR responses are usually presented as the numerical improvement in multiple disease assessment criteria. An ACR 20 response defined as greater than or equal to (>=) 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints).

  15. Health Assessment Questionnaire (HAQ) Responders for Participants who had a Diagnosis of PsA at Screening [ Time Frame: Week 48 ]
    The HAQ-DI.23 This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living) (Attachment 9). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (ie, lower scores are indicative of better functioning).

  16. Change From Baseline in Visual Analogue Scale (VAS) Score [ Time Frame: Baseline and Week 48 ]
    Participants will be asked to assess their average pain during the past week on a VAS. The scale ranges from "no pain" (0 centimeters [cm]) to "the worst possible pain" (10 cm).

  17. Serum Concentration of CNTO 1959 [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24,28, 36, 44, 48, 52 ]
    Serum concentration of CNTO 1959 will be observed.

  18. Serum Concentration of CNTO 1959 Antibodies [ Time Frame: Week 0, 4, 16, 28, 48, 52 ]
  19. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: Baseline and Week 48 ]
    The HAQ-DI.23 This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living) (Attachment 9). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (ie, lower scores are indicative of better functioning).



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.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
  • Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline
  • Have an IGA >= 3 at Screening and at Baseline
  • Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
  • Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)

Exclusion Criteria:

  • Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
  • Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

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): NCT02325219


Locations
Japan
Asahikawa, Japan
Chuo, Japan
Gifu, Japan
Isehara-City, Japan
Izumo, Japan
Kanazawa, Japan
Kawasaki, Japan
Kita-Gun, Japan
Kochi, Japan
Kurume, Japan
Kyoto, Japan
Matsumoto, Japan
Miyagi, Japan
Morioka, Japan
Nagoya, Japan
Osaka-Sayama, Japan
Osaka, Japan
Sapporo, Japan
Shimotsuke, Japan
Shinjuku-Ku, Japan
Tokushima, Japan
Tokyo, Japan
Toon, Japan
Tsukuba, Japan
Tsu, Japan
Ube, Japan
Yokosuka, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02325219     History of Changes
Other Study ID Numbers: CR103833
CNTO1959PSO3004 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Pharmaceutical K.K.:
Psoriasis
CNTO 1959
Guselkumab
Placebo

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases