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NCT02346240: CIMPACT

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)

Completed Phase 3 Results posted Last updated 16 July 2021
What this trial tests

Phase 3 trial testing Certolizumab Pegol in Psoriasis in 559 participants. Completed in 17 December 2018.

Timeline
11 February 2015
Primary endpoint
22 March 2016
17 December 2018

Quick facts

Lead sponsorUCB Biopharma S.P.R.L.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment559
Start date11 February 2015
Primary completion22 March 2016
Estimated completion17 December 2018
Sites70 locations across France, Netherlands, United Kingdom, Germany, Hungary, Poland, Bulgaria, United States

Drugs / interventions tested

Conditions studied

Sponsor

UCB Biopharma S.P.R.L. — full company profile →

Who can join

18 and older, any sex, with Psoriasis or Plaque 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.

Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 Primary · Week 12

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and co

GroupValue95% CI
Placebo Q2W (RS)5.0
Etanercept (RS)53.3
CZP 200 mg Q2W (RS)61.3
CZP 400 mg Q2W (RS)66.7
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12 Secondary · Week 12

The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

GroupValue95% CI
Placebo Q2W (RS)1.9
Etanercept (RS)39.2
CZP 200 mg Q2W (RS)39.8
CZP 400 mg Q2W (RS)50.3
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 Secondary · Week 12

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and co

GroupValue95% CI
Placebo Q2W (RS)0.2
Etanercept (RS)27.1
CZP 200 mg Q2W (RS)31.2
CZP 400 mg Q2W (RS)34.0
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 Secondary · Week 16

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and co

GroupValue95% CI
Placebo Q2W (RS)3.8
CZP 200 mg Q2W (RS)68.2
CZP 400 mg Q2W (RS)74.7
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16 Secondary · Week 16

The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

GroupValue95% CI
Placebo Q2W (RS)3.4
CZP 200 mg Q2W (RS)48.3
CZP 400 mg Q2W (RS)58.4
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 Secondary · Week 16

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and co

GroupValue95% CI
Placebo Q2W (RS)0.3
CZP 200 mg Q2W (RS)39.8
CZP 400 mg Q2W (RS)49.1
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16 Secondary · Week 48

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and co

GroupValue95% CI
Placebo/Placebo Q2W (WK16RS)100
Etanercept/Placebo Q2W (WK16RS)8.3
Etanercept/CZP 200 mg Q2W (WK16RS)82.0
CZP 200 mg Q2W/Placebo Q2W (WK16RS)45.5
CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS)79.5
CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS)88.6
CZP 400 mg Q2W/Placebo Q2W (WK16RS)36.0
CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS)80.0
CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)98.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Q2W (SS) Wk 0-48
Serious: 8/128 (6%)
Deaths: 0/128
Etanercept (SS) Wk 0-12
Serious: 1/168 (1%)
Deaths: 0/168
CZP 200 mg Q2W (SS) Wk 0-144
Serious: 34/373 (9%)
Deaths: 2/373
CZP 400 mg Q2W (SS) Wk 0-144
Serious: 51/412 (12%)
Deaths: 1/412
CZP 400mg Q4W (SS) Wk 16-48
Serious: 5/44 (11%)
Deaths: 0/44

Serious adverse events (113 terms)

ReactionSystemPlacebo Q2W (SS) Wk 0-48Etanercept (SS) Wk 0-12CZP 200 mg Q2W (SS) Wk 0-144CZP 400 mg Q2W (SS) Wk 0-144CZP 400mg Q4W (SS) Wk 16-48
OsteoarthritisMusculoskeletal and connective tissue disorders
PneumoniaInfections and infestations
Wrist fractureInjury, poisoning and procedural complications
MigraineNervous system disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
Intracardiac massCardiac disorders
Coronary artery diseaseCardiac disorders
Cardiac failureCardiac disorders
Acute coronary syndromeCardiac disorders
Acute myocardial infarctionCardiac disorders
Angina pectorisCardiac disorders
Vestibular disorderEar and labyrinth disorders
Tympanic membrane perforationEar and labyrinth disorders
CataractEye disorders
Retinal detachmentEye disorders
Large intestine polypGastrointestinal disorders
Crohn's diseaseGastrointestinal disorders
Abdominal painGastrointestinal disorders
Haemorrhoidal haemorrhageGastrointestinal disorders
HaemorrhoidsGastrointestinal disorders
Inguinal herniaGastrointestinal disorders
Upper gastrointestinal haemorrhageGastrointestinal disorders
Peptic ulcerGastrointestinal disorders
Umbilical herniaGastrointestinal disorders
InflammationGeneral disorders
Other adverse events (7 terms — click to expand)

ReactionSystemPlacebo Q2W (SS) Wk 0-48Etanercept (SS) Wk 0-12CZP 200 mg Q2W (SS) Wk 0-144CZP 400 mg Q2W (SS) Wk 0-144CZP 400mg Q4W (SS) Wk 16-48
NasopharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
HypertensionVascular disorders
Viral upper respiratory tract infectionInfections and infestations
PsoriasisSkin and subcutaneous tissue disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Blood creatine phosphokinase increasedInvestigations

Most-reported serious reactions: Osteoarthritis, Pneumonia, Wrist fracture, Migraine, Chronic obstructive pulmonary disease, Intracardiac mass, Coronary artery disease, Cardiac failure.

Data from ClinicalTrials.gov NCT02346240 adverse events section.

Sponsor's own description

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.

Publications & conference data

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

  1. Old and New Biological Therapies for Psoriasis.
    Rønholt K, Iversen L. · · 2017 · cited 152× · PMID 29104241 · DOI 10.3390/ijms18112297
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. Certolizumab pegol for the treatment of patients with moderate-to-severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials.
    Blauvelt A, Reich K, Lebwohl M, Burge D, et al · · 2019 · cited 28× · PMID 30242918 · DOI 10.1111/jdv.15258
  8. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.
    Blauvelt A, Paul C, van de Kerkhof P, Warren RB, et al · · 2021 · cited 18× · PMID 32531798 · DOI 10.1111/bjd.19314

Verify or expand the search:

Other trials of Certolizumab Pegol

Trials testing the same drug.

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

Other UCB Biopharma S.P.R.L. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02346240.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing