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NCT01483599: X-PLORE

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

Completed Phase 2 Results posted Last updated 2 August 2017
What this trial tests

Phase 2 trial testing CNTO 1959 (5 mg) in Psoriasis in 293 participants. Completed in 5 August 2013.

Timeline
10 November 2011
Primary endpoint
27 November 2012
5 August 2013

Quick facts

Lead sponsorJanssen Inc.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment293
Start date10 November 2011
Primary completion27 November 2012
Estimated completion5 August 2013
Sites40 locations across Belgium, Germany, Poland, Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Inc. — full company profile →

Who can join

Adults 18 to 99, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Placebo7.1
CNTO1959 5 mg34.1
CNTO1959 15 mg61.0
CNTO1959 50 mg78.6
CNTO1959 100 mg85.7
CNTO1959 200 mg83.3
Adalimumab58.1
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 Secondary · 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) t

GroupValue95% CI
Placebo4.8
CNTO1959 5 mg43.9
CNTO1959 15 mg75.6
CNTO1959 50 mg81.0
CNTO1959 100 mg78.6
CNTO1959 200 mg81.0
Adalimumab69.8
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 Secondary · 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).

GroupValue95% CI
CNTO1959 5 mg34.1
CNTO1959 15 mg61.0
CNTO1959 50 mg78.6
CNTO1959 100 mg85.7
CNTO1959 200 mg83.3
Adalimumab58.1
Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40 Secondary · 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).

GroupValue95% CI
CNTO1959 5 mg35.3
CNTO1959 15 mg59.5
CNTO1959 50 mg71.1
CNTO1959 100 mg76.9
CNTO1959 200 mg81.1
Adalimumab48.6
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 Secondary · Baseline and 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 scor

GroupValue95% CI
Placebo-2.3± 6.80
CNTO1959 5 mg-6.2± 5.24
CNTO1959 15 mg-10.3± 5.49
CNTO1959 50 mg-11.1± 7.38
CNTO1959 100 mg-10.8± 7.34
CNTO1959 200 mg-11.4± 6.83
Adalimumab-10.1± 9.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Week 0) up to Week 52. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (CP)
Serious: 1/42 (2%)
Deaths:
CNTO1959 5 mg (CP)
Serious: 0/41 (0%)
Deaths:
CNTO1959 15 mg (CP)
Serious: 0/41 (0%)
Deaths:
CNTO1959 50 mg (CP)
Serious: 3/42 (7%)
Deaths:
CNTO1959 100 mg (CP)
Serious: 0/42 (0%)
Deaths:
CNTO1959 200 mg (CP)
Serious: 0/41 (0%)
Deaths:
Adalimumab (CP)
Serious: 1/43 (2%)
Deaths:
Placebo -> 100 mg CNTO1959 (After CP)
Serious: 0/39 (0%)
Deaths:
CNTO1959 5 mg (After CP)
Serious: 2/38 (5%)
Deaths:
CNTO1959 15 mg (After CP)
Serious: 0/41 (0%)
Deaths:
CNTO1959 50 mg (After CP)
Serious: 0/39 (0%)
Deaths:
CNTO1959 100 mg (After CP)
Serious: 2/40 (5%)
Deaths:
CNTO1959 200 mg (After CP)
Serious: 0/38 (0%)
Deaths:
Adalimumab (After CP)
Serious: 1/38 (3%)
Deaths:

Serious adverse events (12 terms)

ReactionSystemPlacebo (CP)CNTO1959 5 mg (CP)CNTO1959 15 mg (CP)CNTO1959 50 mg (CP)CNTO1959 100 mg (CP)CNTO1959 200 mg (CP)Adalimumab (CP)Placebo -> 100 mg CNTO1959…CNTO1959 5 mg (After CP)CNTO1959 15 mg (After CP)CNTO1959 50 mg (After CP)CNTO1959 100 mg (After CP)CNTO1959 200 mg (After CP)Adalimumab (After CP)
Atrial FlutterCardiac disorders
Myocardial InfarctionCardiac disorders
Oesophagitis HaemorrhagicGastrointestinal disorders
Umbilical HerniaGastrointestinal disorders
AppendicitisInfections and infestations
Lung AbscessInfections and infestations
PneumoniaInfections and infestations
HyperglycaemiaMetabolism and nutrition disorders
OsteoarthritisMusculoskeletal and connective tissue disorders
Cerebrovascular AccidentNervous system disorders
Uterine ProlapseReproductive system and breast disorders
HaematomaVascular disorders
Other adverse events (16 terms — click to expand)

ReactionSystemPlacebo (CP)CNTO1959 5 mg (CP)CNTO1959 15 mg (CP)CNTO1959 50 mg (CP)CNTO1959 100 mg (CP)CNTO1959 200 mg (CP)Adalimumab (CP)Placebo -> 100 mg CNTO1959…CNTO1959 5 mg (After CP)CNTO1959 15 mg (After CP)CNTO1959 50 mg (After CP)CNTO1959 100 mg (After CP)CNTO1959 200 mg (After CP)Adalimumab (After CP)
NasopharyngitisInfections and infestations
Injection Site ErythemaGeneral disorders
Upper Respiratory Tract InfectionInfections and infestations
HeadacheNervous system disorders
PsoriasisSkin and subcutaneous tissue disorders
FatigueGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Back PainMusculoskeletal and connective tissue disorders
HypertensionVascular disorders
Influenza Like IllnessGeneral disorders
GastroenteritisInfections and infestations
InfluenzaInfections and infestations
SinusitisInfections and infestations
Muscle StrainInjury, poisoning and procedural complications
CoughRespiratory, thoracic and mediastinal disorders
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Atrial Flutter, Myocardial Infarction, Oesophagitis Haemorrhagic, Umbilical Hernia, Appendicitis, Lung Abscess, Pneumonia, Hyperglycaemia.

Data from ClinicalTrials.gov NCT01483599 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing.
    Gaffen SL, Jain R, Garg AV, Cua DJ. · · 2014 · cited 1246× · PMID 25145755 · DOI 10.1038/nri3707
  2. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis.
    Gordon KB, Duffin KC, Bissonnette R, Prinz JC, et al · · 2015 · cited 231× · PMID 26154787 · DOI 10.1056/nejmoa1501646
  3. Antibodies to watch in 2016.
    Reichert JM. · · 2016 · cited 135× · PMID 26651519 · DOI 10.1080/19420862.2015.1125583
  4. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Do G, et al · · 2017 · cited 106× · PMID 29271481 · DOI 10.1002/14651858.cd011535.pub2
  5. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
  6. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Afach S, Doney L, et al · · 2020 · cited 78× · PMID 31917873 · DOI 10.1002/14651858.cd011535.pub3
  7. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6
  8. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2021 · cited 54× · PMID 33871055 · DOI 10.1002/14651858.cd011535.pub4

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Other recruiting trials for Psoriasis

Currently open trials in the same condition.

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