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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04533737
Registration number
NCT04533737
Ethics application status
Date submitted
26/08/2020
Date registered
1/09/2020
Date last updated
12/01/2023
Titles & IDs
Public title
Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
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Scientific title
Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab
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Secondary ID [1]
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2019-004099-20
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Secondary ID [2]
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LP0160-1510
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Universal Trial Number (UTN)
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Trial acronym
COBRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
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Psoriasis Vulgaris
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Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Brodalumab
Other interventions - Placebo
Other interventions - Guselkumab
Experimental: Arm 1 (brodalumab + dummy 1) - Participants receive:
Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.
Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks.
Active Comparator: Arm 2 (guselkumab + dummy 2) - Participants receive:
Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks.
Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.
Other interventions: Brodalumab
Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection
Other interventions: Placebo
The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance
Other interventions: Guselkumab
Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Having Psoriasis Area and Severity Index (PASI) 100 response at Week 16
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Assessment method [1]
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Having 100% improvement from baseline in PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, and lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Time to PASI 100 response
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Assessment method [1]
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Time to having 100% improvement from baseline in PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, and lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.
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Timepoint [1]
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up to 28 weeks
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Secondary outcome [2]
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Time to PASI 90 response
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Assessment method [2]
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Time to having 90% improvement from baseline in PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, and lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.
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Timepoint [2]
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up to 28 weeks
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Secondary outcome [3]
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Having PASI 100 response, assessed separately at Weeks 4, 8, and 28
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Assessment method [3]
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Having 100% improvement from baseline in PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, and lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.
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Timepoint [3]
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Weeks 4, 8, and 28
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Secondary outcome [4]
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Having PASI 90 response, assessed separately at Weeks 4, 8, 16, and 28
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Assessment method [4]
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Having 90% improvement from baseline in PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess the severity and extent of psoriasis. The assessment is done based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, and lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.
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Timepoint [4]
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Weeks 4, 8, 16, and 28
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Secondary outcome [5]
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Having Investigator's Global Assessment (IGA) of 0, assessed separately at Week 16 and Week 28.
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Assessment method [5]
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Having a score of 0 (clear) in IGA. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
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Timepoint [5]
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Weeks 16 and 28
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Secondary outcome [6]
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Having IGA of 0 or 1, assessed separately at Week 16 and Week 28.
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Assessment method [6]
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Having a score of 0 (clear) or 1 (almost clear) in IGA. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
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Timepoint [6]
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Weeks 16 and 28
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Secondary outcome [7]
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Having Dermatology Life Quality Index (DLQI) total score of 0 or 1, assessed separately at Weeks 4, 8, 12, 16, 20, 24, and 28.
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Assessment method [7]
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The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all/not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
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Timepoint [7]
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Weeks 4, 8, 12, 16, 20, 24, and 28.
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Secondary outcome [8]
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Change in 36-Item Short Form Health Survey version 2 (SF-36v2) score from baseline, assessed separately at Weeks 4, 8, 16, and 28.
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Assessment method [8]
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The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary).
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Timepoint [8]
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Weeks 4, 8, 16, and 28.
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Secondary outcome [9]
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Occurrence of treatment-emergent adverse events (AEs) from baseline to Week 28.
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Assessment method [9]
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An adverse event is considered treatment-emergent if the onset occurred after the first administration of IMP or if the event started prior to the first administration of IMP and worsened in severity after the first administration of IMP.
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Timepoint [9]
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From baseline to Week 28
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Eligibility
Key inclusion criteria
Key
- Participant has a diagnosis of plaque psoriasis for at least 6 months before the first
administration of investigational medicinal product (IMP) as determined by the
investigator.
- Participant has inadequately controlled plaque psoriasis currently treated with
ustekinumab, and fulfils ALL of the following criteria:
1. Ustekinumab administered at least 3 times at or higher than the approved dose or
frequency before randomisation.
2. IGA =2 at screening and baseline.
3. Absolute PASI >3 at screening and baseline.
- Participant has no evidence of active tuberculosis according to local standard of care
for patients requiring initiation of a biologic treatment. Participants with
adequately treated latent tuberculosis, according to local guidelines, are eligible.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate
psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that
would interfere with evaluations of the effect of IMP on plaque psoriasis.
- Participant has clinically important active infections or infestations, chronic,
recurrent, or latent infections or infestations, or is immunocompromised (e.g. human
immunodeficiency virus).
- Participant has any systemic disease (e.g. renal failure, heart failure, hypertension,
liver disease, diabetes, anaemia) considered by the investigator to be clinically
significant and uncontrolled.
- Participant has a known history of Crohn's disease.
- Participant has any active malignancy, including evidence of cutaneous basal or
squamous cell carcinoma or melanoma.
- Participant has a history of malignancy within 5 years, except for treated and
considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer,
or in situ breast ductal carcinoma.
- Participant has a known history of active tuberculosis.
- Participant has a history of suicidal behaviour (i.e. 'actual suicide attempt',
'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on
the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or
baseline.
- Participant has any suicidal ideation of severity 4 or 5 ('some intent to act, no
plan' or 'specific plan and intent') based on the C-SSRS questionnaire at screening or
baseline.
- Participant has a Patient Health Questionnaire-8 (PHQ-8) score of =10, corresponding
to moderate to severe depression at screening or baseline.
- Participant has previously been treated with any anti-interleukin (IL)-17A, anti-IL 17
receptor subunit A, or anti-IL-23 besides ustekinumab.
- Participant has known or suspected hypersensitivity to any component(s) of the IMPs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2020
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2022
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Sample size
Target
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Accrual to date
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Final
113
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Herstal
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Belgium
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Namur
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France
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Bouches-du-Rhône
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France
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Seine-Maritime 10
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France
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Val-de-Marne
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France
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Nice
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France
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Toulouse
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Germany
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Baden-Wuerttemberg
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Germany
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Aachen
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Augsburg
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Germany
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Bad Bentheim
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Germany
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Bonn
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Bramsche
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Germany
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Buxtehude
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Erlangen
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Mainz
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Germany
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Memmingen
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Germany
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Münster
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Germany
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Selters
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Greece
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Athens
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Nea Efkarpía
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Thessaloníki
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Italy
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Napoli
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Italy
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Italy
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Italy
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Asturias
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Vizcaya
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Alicante
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Barcelona
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Granada
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Spain
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Madrid
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Spain
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Pontevedra
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Spain
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Valencia
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Sweden
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Stockholm
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Switzerland
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Saint Gallen
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Switzerland
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Zürich
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United Kingdom
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Avon
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United Kingdom
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United Kingdom
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
LEO Pharma
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment
for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms
after ustekinumab treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04533737
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Medical Expert
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Address
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LEO Pharma
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04533737
Download to PDF