PsoriasisPhase 3NCT03219437
A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing risankizumab and methotrexate in people with Psoriasis, run by AbbVie at 11 sites in Brazil.
Trial summary
The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- risankizumab and methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 11 sitesBrazil
- Study dates
- 30 Jul 2018to 26 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug
- Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits
- Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator
- Be a candidate for treatment with methotrexate (MTX) according to local label
Who cannot join
- Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment
- Previous exposure to risankizumab
- Previous exposure to MTX
- Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
- Subject has a history of clinically significant hematologic, renal, or liver disease
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743
Botucatu, São Paulo, 18618-686
Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521
Campinas, São Paulo, 13083-888
CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593
Curitiba, Paraná, 80030-110
PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401
Curitiba, Paraná, 80230-130
Hospital Moinhos de Vento /ID# 208592
Porto Alegre, Rio Grande do Sul, 90035-001
Hospital de Clinicas de Porto Alegre /ID# 164565
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768
Ribeirão Preto, São Paulo, 14051-140
Instituto de Dermatologia e Estética do Brasil /ID# 164754
Rio de Janeiro, 22470-220
Faculdade de Medicina do ABC /ID# 164519
Santo André, São Paulo, 09060-870
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723
São José do Rio Preto, São Paulo, 15090-000
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805
São Paulo, 05403-000
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- risankizumab, methotrexate
- Keywords
- ABBV-066, BI 655066
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risankizumabDrug
Also called ABBV-066, BI 655066
subcutaneous (SC) injection
methotrexateDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Active comparator | Participants to receive double-blind methotrexate. Receives: Drug: methotrexate |
| Risankizumab | Experimental | Participants to receive double-blind risankizumab. Receives: Drug: risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28.
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Measured: Week 28
Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28
PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Measured: Week 28
Secondary outcomes (5)
Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28
PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Measured: Week 28
Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28
PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Measured: Week 28
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Measured: Week 28
Change from baseline in EQ-5D-5L at all visits collected
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life.
Measured: Week 28
Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits
The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start30 Jul 2018
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219437
- Sponsor's protocol ID
- M16-177
- Status last verified
- Nov 2022
- First submitted
- 14 Jul 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03219437
- Acronym / sponsor ID
- M16-177
- Conditions
- Psoriasis
- Keywords
- ABBV-066, BI 655066
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Active comparator | Drug: methotrexateParticipants to receive double-blind methotrexate. |
| Risankizumab | Experimental | Drug: risankizumabParticipants to receive double-blind risankizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug
- Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits
- Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator
- Be a candidate for treatment with methotrexate (MTX) according to local label
Key exclusion criteria (5 listed)
- Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment
- Previous exposure to risankizumab
- Previous exposure to MTX
- Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
- Subject has a history of clinically significant hematologic, renal, or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risankizumabAlso: ABBV-066, BI 655066subcutaneous (SC) injection | Drug | Risankizumab |
| methotrexatecapsule | Drug | Methotrexate |
Primary outcome
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28.
Time frame: Week 28
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28
Time frame: Week 28
PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
5 secondary outcomes
Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28
Time frame: Week 28
Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28
Time frame: Week 28
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28
Time frame: Week 28
Change from baseline in EQ-5D-5L at all visits collected
Time frame: Week 28
Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits
Time frame: Week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risankizumab and methotrexate in people with Psoriasis, run by AbbVie at 11 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. (time frame: Week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.