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PsoriasisPhase 2X-PLORENCT01483599

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

A Phase 2 study testing CNTO 1959 (5 mg), CNTO 1959 (15 mg) and CNTO 1959 (50 mg) in people with Psoriasis, run by Janssen Inc. at 40 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Psoriasis
What is being tested?
CNTO 1959 (5 mg), CNTO 1959 (15 mg) and CNTO 1959 (50 mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
293 participants
Where
40 sitesin 5 countries
Study dates
10 Nov 2011to 5 Aug 2013
Phase
Phase 2
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 5 countries.

40 sites in 5 countries

United States18 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alpharetta, Georgia

  • Study site

    Andover, Massachusetts

  • Study site

    Arlington Heights, Illinois

  • Study site

    Bakersfield, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    New York, New York

  • Study site

    Ocala, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Santa Monica, California

  • Study site

    Skokie, Illinois

  • Study site

    St Louis, Missouri

Other trials in United States

Canada11 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    London, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    Oakville, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Waterloo, Ontario

Other trials in Canada

Germany4 sites

  • Study site

    Hamburg

  • Study site

    Mahlow

  • Study site

    Münster

  • Study site

    Schwerin

Other trials in Germany

Poland4 sites

  • Study site

    Gdansk

  • Study site

    Gmina Końskie

  • Study site

    Lodz

  • Study site

    Wroclaw

Other trials in Poland

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Liège

Other trials in Belgium

About this study

Official title: A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

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.

Read the detailed description

This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.

Conditions
Psoriasis
Being tested
CNTO 1959 (5 mg), CNTO 1959 (15 mg), CNTO 1959 (50 mg), CNTO 1959 (100 mg), CNTO 1959 (200 mg)
Keywords
Moderate to Severe Plaque-Type Psoriasis, Psoriasis, Plaque-type psoriasis, CNTO 1959, adalimumab
Medical subject headings
Psoriasis

What participants receive

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

  • CNTO 1959 (5 mg)Drug

    Subcutaneous (SC) injections

  • CNTO 1959 (15 mg)Drug

    SC injections

  • CNTO 1959 (50 mg)Drug

    SC injections

  • CNTO 1959 (100 mg)Drug

    SC injections

  • CNTO 1959 (200 mg)Drug

    SC injections

  • AdalimumabDrug

    SC injections

  • PlaceboDrug

    SC injections

Study groups in NCT01483599
Study groupRoleWhat they receive
CNTO 1959 (5 mg)ExperimentalCNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
Receives: Drug: CNTO 1959 (5 mg)
CNTO 1959 (15 mg)ExperimentalCNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
Receives: Drug: CNTO 1959 (15 mg)
CNTO 1959 (50 mg)ExperimentalCNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
Receives: Drug: CNTO 1959 (50 mg)
CNTO 1959 (100 mg)ExperimentalCNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
Receives: Drug: CNTO 1959 (100 mg)
CNTO 1959 (200 mg)ExperimentalCNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
Receives: Drug: CNTO 1959 (200 mg)
Adalimumab (approved psoriasis dosing)Active comparatorAdalimumab 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.)
Receives: Drug: Adalimumab
Placebo to CNTO 1959 (100 mg)Placebo comparatorPlacebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
Receives: Drug: CNTO 1959 (100 mg); Drug: Placebo

What is being measured

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

  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).

    Measured: Week 16

Secondary outcomes (4)

  1. Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 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 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

    Measured: Week 16

  2. 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

    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).

    Measured: Week 16

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

    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).

    Measured: Week 40

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

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

    Measured: Baseline and Week 16

Timeline

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

  1. First posted1 Dec 2011 (estimated)
  2. Study start10 Nov 2011
  3. Primary completion27 Nov 2012
  4. Study completion5 Aug 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
293 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01483599
Sponsor's protocol ID
CR100673
Other IDs
CNTO1959PSO2001, 2011-001066-17
Acronym
X-PLORE
Status last verified
Jul 2017
First submitted
29 Nov 2011
Last updated
2 Aug 2017
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37906417

  • 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.

    PubMed 26154787

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CNTO 1959 (5 mg), CNTO 1959 (15 mg) and CNTO 1959 (50 mg) in people with Psoriasis, run by Janssen Inc. at 40 sites in 5 countries.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. 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 2 Aug 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, Canada, Germany, Poland, Belgium. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Aug 2017). 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?

Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (time frame: Week 16). 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 NCT01483599, 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 2 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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