A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis

NCT01483599 | Completed Phase 2 Results DMC

• 3 other identifiers: CR100673CNTO1959PSO20012011-001066-17
• Study Type: interventional
• Target: 293
• Locations: 5 countries
• Sites: 40

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

Moderate to Severe Plaque-Type Psoriasis; Psoriasis; Plaque-type psoriasis; CNTO 1959; adalimumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16

  PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema \[0 (no evidence of plaque) to 5 (dusky to deep red coloration)\], induration \[0 (no plaque evaluation) to 5 (marked plaque evaluation)\] and scaling \[0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)\]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).

  Week 16

Secondary Outcomes (4)

• Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16

  Week 16

• Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16

  Week 16

• Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40

  Week 40

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

  Baseline and Week 16

Study Arms (7)

CNTO 1959 (5 mg)

EXPERIMENTAL

CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40

Drug: CNTO 1959 (5 mg)

CNTO 1959 (15 mg)

EXPERIMENTAL

CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40

Drug: CNTO 1959 (15 mg)

CNTO 1959 (50 mg)

EXPERIMENTAL

CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40

Drug: CNTO 1959 (50 mg)

CNTO 1959 (100 mg)

EXPERIMENTAL

CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40

Drug: CNTO 1959 (100 mg)

CNTO 1959 (200 mg)

EXPERIMENTAL

CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40

Drug: CNTO 1959 (200 mg)

Adalimumab (approved psoriasis dosing)

ACTIVE COMPARATOR

Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)

Drug: Adalimumab

Placebo to CNTO 1959 (100 mg)

PLACEBO COMPARATOR

Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40

Drug: CNTO 1959 (100 mg); Drug: Placebo

Interventions

CNTO 1959 (5 mg) DRUG

Subcutaneous (SC) injections

CNTO 1959 (5 mg)

CNTO 1959 (15 mg) DRUG

SC injections

CNTO 1959 (15 mg)

CNTO 1959 (50 mg) DRUG

SC injections

CNTO 1959 (50 mg)

CNTO 1959 (100 mg) DRUG

SC injections

CNTO 1959 (100 mg); Placebo to CNTO 1959 (100 mg)

CNTO 1959 (200 mg) DRUG

SC injections

CNTO 1959 (200 mg)

Adalimumab DRUG

SC injections

Adalimumab (approved psoriasis dosing)

Placebo DRUG

SC injections

Placebo to CNTO 1959 (100 mg)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
• Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
• Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
• If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
• If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.

You may not qualify if:

• History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
• Has a contra-indication to anti-TNF therapy
• Has a history of chronic or recurrent infectious disease
• Has a nonplaque form of psoriasis or has drug-induced psoriasis
• Has been previously treated with adalimumab
• Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab \[ABT-874\], AIN457, and SCH900222) within 6 months of the first administration of study agent.

Sponsors & Collaborators

• Janssen Inc.: lead

Study Sites (40)

Unknown Facility

Birmingham, Alabama, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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Santa Monica, California, United States

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Ocala, Florida, United States

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Alpharetta, Georgia, United States

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Arlington Heights, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Andover, Massachusetts, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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Brussels, Belgium

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Ghent, Belgium

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Liège, Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Hamburg, Germany

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Mahlow, Germany

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Münster, Germany

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Schwerin, Germany

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Gdansk, Poland

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Gmina Końskie, Poland

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Lodz, Poland

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Wroclaw, Poland

Location

Related Publications (2)

• Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

  PMID: 37906417 DERIVED

• Gordon KB, Duffin KC, Bissonnette R, Prinz JC, Wasfi Y, Li S, Shen YK, Szapary P, Randazzo B, Reich K. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis. N Engl J Med. 2015 Jul 9;373(2):136-44. doi: 10.1056/NEJMoa1501646.

  PMID: 26154787 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab; Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Director, Clinical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: November 10, 2011
• Primary Completion: November 27, 2012
• Study Completion: August 5, 2013
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-07

Locations

US (18); CA (11); DE (4); PL (4); BE (3)