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PsoriasisPhase 3PSTELLARNCT01550744

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

A Phase 3 study testing Ustekinumab 45 mg and Ustekinumab 90 mg in people with Psoriasis, run by Janssen Biotech, Inc. at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Psoriasis
What is being tested?
Ustekinumab 45 mg and Ustekinumab 90 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
478 participants
Where
40 sitesUnited States
Study dates
Mar 2012to Jul 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Study site

    Arlington, Texas

  • Study site

    Bakersfield, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Bridgeport, Connecticut

  • Study site

    Chicago, Illinois

  • Study site

    Clarksburg, West Virginia

  • Study site

    Coral Gables, Florida

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    East Windsor, New Jersey

  • Study site

    Fridley, Minnesota

  • Study site

    Gahanna, Ohio

  • Study site

    Henderson, Nevada

  • Study site

    Indianapolis, Indiana

  • Study site

    Irvine, California

  • Study site

    Johnston, Rhode Island

  • Study site

    Lebanon, New Hampshire

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Norman, Oklahoma

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plainfield, Indiana

  • Study site

    Portland, Oregon

  • Study site

    Saint Augustine, Florida

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Monica, California

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Troy, Michigan

  • Study site

    Williamsville, New York

  • Study site

    Yardley, Pennsylvania

Other trials in United States

About this study

Official title: A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

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.

Read the detailed description

In this study, a proportion of subjects will receive study agent at its recommended dose and interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than 100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will have the opportunity to receive study agent less frequently during the randomization period depending on the subject's response. The study consists of a 4-week screening period; a 28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be randomized for the double blind period into one of two study groups. Group 1 participants will receive an injection of the study medication at a 12 week dosing interval. Group 2 participants will undergo a placebo withdrawal and may receive study agents at an extended interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups 1 and 2 will receive placebo as necessary to maintain the blind.

Conditions
Psoriasis
Being tested
Ustekinumab 45 mg, Ustekinumab 90 mg, Placebo
Keywords
Psoriasis, Ustekinumab, STELARA, Skin disease, Monoclonal
Medical subject headings
Psoriasis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ustekinumab 45 mgDrug

    Form = Injection, route = subcutaneous

  • Ustekinumab 90 mgDrug

    Form = Injection, route = subcutaneous

  • PlaceboDrug

    Form = Injection, route = subcutaneous

Study groups in NCT01550744
Study groupRoleWhat they receive
Group 1: Approved q12w maintenance regimenExperimentalActive ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind
Receives: Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg; Drug: Placebo
Group 2: Subject-tailored fixed-interval maintenance regimenExperimentalSubjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.
Receives: Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

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

    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.

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

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

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.

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

  3. The Percentage of Participants With a PASI 75 Response Over Time

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01550744
Sponsor's protocol ID
CR100708
Other IDs
CNTO1275PSO3009
Acronym
PSTELLAR
Status last verified
Dec 2016
First submitted
8 Mar 2012
Last updated
9 Feb 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29559344

  • 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.

    PubMed 28600818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab 45 mg and Ustekinumab 90 mg in people with Psoriasis, run by Janssen Biotech, Inc. at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) (time frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01550744, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.

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