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NCT02326272: CIMPASI-2

A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

Completed Phase 3 Results posted Last updated 3 October 2019
What this trial tests

Phase 3 trial testing Certolizumab Pegol in Psoriasis in 227 participants. Completed in 12 September 2018.

Timeline
15 December 2014
Primary endpoint
5 January 2016
12 September 2018

Quick facts

Lead sponsorUCB Biopharma S.P.R.L.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment227
Start date15 December 2014
Primary completion5 January 2016
Estimated completion12 September 2018
Sites23 locations across Austria, Canada, United States, Poland

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 Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 Primary · 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 con

GroupValue95% CI
Placebo Q2W (RS)11.6
CZP 200 mg Q2W (RS)81.4
CZP 400 mg Q2W (RS)82.6
Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16 Primary · 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)2.0
CZP 200 mg Q2W (RS)66.8
CZP 400 mg Q2W (RS)71.6
Proportion of Participants 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 con

GroupValue95% CI
Placebo Q2W (RS)4.5
CZP 200 mg Q2W (RS)52.6
CZP 400 mg Q2W (RS)55.4
Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48 Secondary · Week 48

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
CZP 200 mg Q2W (RS)72.661.22 – 83.92
CZP 400 mg Q2W (RS)66.654.35 – 78.86
Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 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 con

GroupValue95% CI
CZP 200 mg Q2W (RS)78.768.93 – 88.45
CZP 400 mg Q2W (RS)81.371.90 – 90.67
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Secondary · Week 16

The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (\>=) 4-point change in the DLQI score

GroupValue95% CI
Placebo Q2W (RS)-3.8± 0.84
CZP 200 mg Q2W (RS)-10.4± 0.62
CZP 400 mg Q2W (RS)-10.0± 0.64

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CZP 200 mg Q2W (TCS)
Serious: 24/170 (14%)
Deaths: 1/170
CZP 400 mg Q2W (TCS)
Serious: 12/149 (8%)
Deaths: 1/149

Serious adverse events (49 terms)

ReactionSystemCZP 200 mg Q2W (TCS)CZP 400 mg Q2W (TCS)
Drug-induced liver injuryHepatobiliary disorders
Psoriatic arthropathyMusculoskeletal and connective tissue disorders
Transient ischaemic attackNervous system disorders
Disseminated intravascular coagulationBlood and lymphatic system disorders
Cardiac failure congestiveCardiac disorders
Tolosa-Hunt syndromeEye disorders
Haemorrhagic necrotic pancreatitisGastrointestinal disorders
ColitisGastrointestinal disorders
Pharyngo-oesophageal diverticulumGastrointestinal disorders
Abdominal painGastrointestinal disorders
Rectal haemorrhageGastrointestinal disorders
Chest painGeneral disorders
Hepatic failureHepatobiliary disorders
Anaphylactic reactionImmune system disorders
Abdominal abscessInfections and infestations
AppendicitisInfections and infestations
CellulitisInfections and infestations
Bartholin's abscessInfections and infestations
Ovarian abscessInfections and infestations
VaricellaInfections and infestations
Infected biteImmune system disorders
Pneumonia legionellaInfections and infestations
Chronic sinusitisInfections and infestations
Urinary tract infectionInfections and infestations
Haematoma infectionInfections and infestations
Other adverse events (11 terms — click to expand)

ReactionSystemCZP 200 mg Q2W (TCS)CZP 400 mg Q2W (TCS)
NasopharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
SinusitisInfections and infestations
PsoriasisSkin and subcutaneous tissue disorders
Urinary tract infectionInfections and infestations
PharyngitisInfections and infestations
HeadacheNervous system disorders
HypertensionVascular disorders
Ligament sprainInjury, poisoning and procedural complications
ArthralgiaMusculoskeletal and connective tissue disorders
PruritusSkin and subcutaneous tissue disorders

Most-reported serious reactions: Drug-induced liver injury, Psoriatic arthropathy, Transient ischaemic attack, Disseminated intravascular coagulation, Cardiac failure congestive, Tolosa-Hunt syndrome, Haemorrhagic necrotic pancreatitis, Colitis.

Data from ClinicalTrials.gov NCT02326272 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 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. Psoriasis as a Systemic Disease.
    Mrowietz U, Lauffer F, Sondermann W, Gerdes S, et al · · 2024 · cited 32× · PMID 38657176 · DOI 10.3238/arztebl.m2024.0064
  8. 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

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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