A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

NCT01550744 | Completed Phase 3 Results DMC

• 2 other identifiers: CR100708CNTO1275PSO3009
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 40

Brief Summary

The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; Ustekinumab; STELARA; Skin disease; Monoclonal

Outcome Measures

Primary Outcomes (1)

• The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)

  Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.

  Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])

Secondary Outcomes (3)

• The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time

  Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112

• The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response

  Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])

• The Percentage of Participants With a PASI 75 Response Over Time

  Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112

Study Arms (2)

Group 1: Approved q12w maintenance regimen

EXPERIMENTAL

Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind

Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg; Drug: Placebo

Group 2: Subject-tailored fixed-interval maintenance regimen

EXPERIMENTAL

Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.

Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg; Drug: Placebo

Interventions

Ustekinumab 45 mg DRUG

Form = Injection, route = subcutaneous

Group 1: Approved q12w maintenance regimen; Group 2: Subject-tailored fixed-interval maintenance regimen

Ustekinumab 90 mg DRUG

Form = Injection, route = subcutaneous

Group 1: Approved q12w maintenance regimen; Group 2: Subject-tailored fixed-interval maintenance regimen

Placebo DRUG

Form = Injection, route = subcutaneous

Group 1: Approved q12w maintenance regimen; Group 2: Subject-tailored fixed-interval maintenance regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Key Eligibility Criteria * Male or female * Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first administration of study agent (subjects with concurrent psoriatic arthritis may be enrolled). * Have plaque-type psoriasis covering at least 10% of their total BSA at screening and at the time of the first administration of study agent. * Have a PGA score of ≥ 3 at screening and at the time of the first administration of study agent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Janssen Biotech, Inc.: lead

Study Sites (40)

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Birmingham, Alabama, United States

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Bakersfield, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Denver, Colorado, United States

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Bridgeport, Connecticut, United States

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Coral Gables, Florida, United States

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Saint Augustine, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Plainfield, Indiana, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Troy, Michigan, United States

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Fridley, Minnesota, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Lebanon, New Hampshire, United States

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East Windsor, New Jersey, United States

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New York, New York, United States

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The Bronx, New York, United States

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Williamsville, New York, United States

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Gahanna, Ohio, United States

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Norman, Oklahoma, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Clarksburg, West Virginia, United States

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Related Publications (2)

• Loesche MA, Farahi K, Capone K, Fakharzadeh S, Blauvelt A, Duffin KC, DePrimo SE, Munoz-Elias EJ, Brodmerkel C, Dasgupta B, Chevrier M, Smith K, Horwinski J, Tyldsley A, Grice EA. Longitudinal Study of the Psoriasis-Associated Skin Microbiome during Therapy with Ustekinumab in a Randomized Phase 3b Clinical Trial. J Invest Dermatol. 2018 Sep;138(9):1973-1981. doi: 10.1016/j.jid.2018.03.1501. Epub 2018 Mar 17.

  PMID: 29559344 DERIVED

• Blauvelt A, Ferris LK, Yamauchi PS, Qureshi A, Leonardi CL, Farahi K, Fakharzadeh S, Hsu MC, Li S, Chevrier M, Smith K, Goyal K, Chen Y, Munoz-Elias EJ, Callis Duffin K. Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR). Br J Dermatol. 2017 Dec;177(6):1552-1561. doi: 10.1111/bjd.15722. Epub 2017 Nov 16.

  PMID: 28600818 DERIVED

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; 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 Research
• Organization: Janssen Biotech, Inc

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Biotech, Inc. Clinical Trial

  Janssen Biotech, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 9, 2017
• Results First Posted: November 7, 2016

Record last verified: 2016-12

Locations

US (40)