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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04533737




Registration number
NCT04533737
Ethics application status
Date submitted
26/08/2020
Date registered
1/09/2020
Date last updated
13/08/2024

Titles & IDs
Public title
Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
Scientific title
Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab
Secondary ID [1] 0 0
2019-004099-20
Secondary ID [2] 0 0
LP0160-1510
Universal Trial Number (UTN)
Trial acronym
COBRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Having Psoriasis Area and Severity Index (PASI) 100 response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Time to PASI 100 response
Timepoint [1] 0 0
up to 28 weeks
Secondary outcome [2] 0 0
Time to PASI 90 response
Timepoint [2] 0 0
up to 28 weeks
Secondary outcome [3] 0 0
Having PASI 100 response, assessed separately at Weeks 4, 8, and 28
Timepoint [3] 0 0
Weeks 4, 8, and 28
Secondary outcome [4] 0 0
Having PASI 90 response, assessed separately at Weeks 4, 8, 16, and 28
Timepoint [4] 0 0
Weeks 4, 8, 16, and 28
Secondary outcome [5] 0 0
Having Investigator's Global Assessment (IGA) of 0, assessed separately at Week 16 and Week 28.
Timepoint [5] 0 0
Weeks 16 and 28
Secondary outcome [6] 0 0
Having IGA of 0 or 1, assessed separately at Week 16 and Week 28.
Timepoint [6] 0 0
Weeks 16 and 28
Secondary outcome [7] 0 0
Having Dermatology Life Quality Index (DLQI) total score of 0 or 1, assessed separately at Weeks 4, 8, 12, 16, 20, 24, and 28.
Timepoint [7] 0 0
Weeks 4, 8, 12, 16, 20, 24, and 28.
Secondary outcome [8] 0 0
Change in 36-Item Short Form Health Survey version 2 (SF-36v2) score from baseline, assessed separately at Weeks 4, 8, 16, and 28.
Timepoint [8] 0 0
Weeks 4, 8, 16, and 28.
Secondary outcome [9] 0 0
Occurrence of treatment-emergent adverse events (AEs) from baseline to Week 28.
Timepoint [9] 0 0
From baseline to Week 28

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.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/12/2022
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Herstal
Country [4] 0 0
Belgium
State/province [4] 0 0
Namur
Country [5] 0 0
France
State/province [5] 0 0
Bouches-du-Rhône
Country [6] 0 0
France
State/province [6] 0 0
Seine-Maritime 10
Country [7] 0 0
France
State/province [7] 0 0
Val-de-Marne
Country [8] 0 0
France
State/province [8] 0 0
Nice
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Germany
State/province [10] 0 0
Baden-Wuerttemberg
Country [11] 0 0
Germany
State/province [11] 0 0
Aachen
Country [12] 0 0
Germany
State/province [12] 0 0
Augsburg
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Bentheim
Country [14] 0 0
Germany
State/province [14] 0 0
Bonn
Country [15] 0 0
Germany
State/province [15] 0 0
Bramsche
Country [16] 0 0
Germany
State/province [16] 0 0
Buxtehude
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Frankfurt am Main
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Germany
State/province [20] 0 0
Kiel
Country [21] 0 0
Germany
State/province [21] 0 0
Mainz
Country [22] 0 0
Germany
State/province [22] 0 0
Memmingen
Country [23] 0 0
Germany
State/province [23] 0 0
Münster
Country [24] 0 0
Germany
State/province [24] 0 0
Selters
Country [25] 0 0
Greece
State/province [25] 0 0
Athens
Country [26] 0 0
Greece
State/province [26] 0 0
Nea Efkarpía
Country [27] 0 0
Greece
State/province [27] 0 0
Thessaloníki
Country [28] 0 0
Italy
State/province [28] 0 0
Napoli
Country [29] 0 0
Italy
State/province [29] 0 0
Pisa
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Italy
State/province [31] 0 0
Rozzano
Country [32] 0 0
Spain
State/province [32] 0 0
Asturias
Country [33] 0 0
Spain
State/province [33] 0 0
Vizcaya
Country [34] 0 0
Spain
State/province [34] 0 0
Alicante
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Granada
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Pontevedra
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
Sweden
State/province [40] 0 0
Stockholm
Country [41] 0 0
Switzerland
State/province [41] 0 0
Saint Gallen
Country [42] 0 0
Switzerland
State/province [42] 0 0
Zürich
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Avon
Country [44] 0 0
United Kingdom
State/province [44] 0 0
West Midlands
Country [45] 0 0
United Kingdom
State/province [45] 0 0
West Yorkshire
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LEO Pharma
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04533737
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Medical Expert
Address 0 0
LEO Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04533737