An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

NCT02325219 | Completed Phase 3 Results DMC

• 2 other identifiers: CR103833CNTO1959PSO3004
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 27

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).

Conditions

Psoriasis

Keywords

Psoriasis; CNTO 1959; Guselkumab; Placebo

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

  The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  Week 16

• Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at 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 the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-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. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.

  Week 16

Secondary Outcomes (45)

• Percentage of Participants Who Achieved PASI 75 Response at Week 16

  Week 16

• Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16

  Baseline and Week 16

• Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16

  Weeks 2, 4, 8, 12, and 16

• Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

  Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

• Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16

  Weeks 2, 4, 8, 12, and 16

Study Arms (3)

Group 1

EXPERIMENTAL

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; Drug: Placebo 100 mg

Group 2

EXPERIMENTAL

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; Drug: Placebo 50 mg

Group 3

EXPERIMENTAL

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; Drug: CTNO 1959 100 mg; Drug: Placebo 50 mg; Drug: Placebo 100 mg

Interventions

CNTO 1959 50 mg DRUG

Participants will receive subcutaneous injection of CNTO 1959 50 mg.

Also known as: Guselkumab

Group 1; Group 3

CTNO 1959 100 mg DRUG

Participants will receive subcutaneous injection of CNTO 1959 100 mg.

Also known as: Guselkumab

Group 2; Group 3

Placebo 50 mg DRUG

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

Group 2; Group 3

Placebo 100 mg DRUG

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

Group 1; Group 3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (27)

Unknown Facility

Asahikawa, Japan

Location

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Chūō, Japan

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Gifu, Japan

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Isehara, Japan

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Izumo, Japan

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Kanazawa, Japan

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Kawasaki, Japan

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Kita-Gun, Japan

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Kochi, Japan

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Kurume, Japan

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Kyoto, Japan

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Matsumoto, Japan

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Miyagi, Japan

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Morioka, Japan

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Nagoya, Japan

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Osaka, Japan

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Ōsaka-sayama, Japan

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Sapporo, Japan

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Shimotsuke, Japan

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Shinjuku-ku, Japan

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Tokushima, Japan

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Tokyo, Japan

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Tōon, Japan

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Tsu, Japan

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Tsukuba, Japan

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Ube, Japan

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Yokosuka, Japan

Location

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Pharmaceutical K.K., Japan

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: December 19, 2014
• Primary Completion: March 2, 2016
• Study Completion: February 8, 2019
• Last Updated: May 22, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Locations

JP (27)