Plaque-type PsoriasisPhase 3STATURENCT01412944
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
A Phase 3 study testing secukinumab 150mg and secukinumab 10mg/kg i.v. regimen in people with Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 27 sites in 8 countries.
Trial summary
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque-type Psoriasis
- What is being tested?
- secukinumab 150mg and secukinumab 10mg/kg i.v. regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 27 sitesin 8 countries
- Study dates
- Dec 2011to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written Informed Consent must be obtained before any assessment is performed,
- Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
- A partial response is defined as having achieved ≥ PASI 50 but < 75 response.
Who cannot join
- Pregnant women or lactating women
- Forms of psoriasis other than chronic plaque -type
- Ongoing use of prohibited psoriasis treatments
- Ongoing use of other non-psoriasis prohibited treatments
- Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
- Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
- UV therapy or excessive exposure to sunlight
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
United States6 sites
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Greensboro, North Carolina, 27401
Novartis Investigative Site
Greer, South Carolina, 29651
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
West Palm Beach, Florida, 33409
Germany5 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mainz, 55131
Japan4 sites
Novartis Investigative Site
Hachiōji, Tokyo, 193-0998
Novartis Investigative Site
Kisarazu, Chiba, 292-8535
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Austria3 sites
Novartis Investigative Site
Graz, A-8036
Novartis Investigative Site
Vienna, A-1220
Novartis Investigative Site
Wels, Austria, 4600
Canada3 sites
Novartis Investigative Site
Barrie, Ontario, L4M 6L2
Novartis Investigative Site
Montreal, Quebec, H2K 4L5
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
India3 sites
Novartis Investigative Site
Mangalore, Karnataka, 575 004
Novartis Investigative Site
Nagpur, Maharashtra, 440 010
Novartis Investigative Site
Nashik, Maharashtra, 422 001
France2 sites
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Toulouse, France, 31059
About this study
Official title: A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
- Conditions
- Plaque-type Psoriasis
- Being tested
- secukinumab 150mg, secukinumab 10mg/kg i.v. regimen
- Keywords
- Psoriasis, plaque, inflammatory skin disease, scaly patches, AIN457, secukinumab, Moderate to severe
- Medical subject headings
- Psoriasis, Plaque, Amyloid, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumab 150mgDrug
secukinumab 150mg (2 injections per dose)
secukinumab 10mg/kg i.v. regimenDrug
secukinumab 10mg/kg i.v. regimen
| Study group | Role | What they receive |
|---|---|---|
| AIN457 subcutaneous (s.c.) | Experimental | During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457. Receives: Drug: secukinumab 150mg |
| AIN457 I.V. | Experimental | During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457. Receives: Drug: secukinumab 10mg/kg i.v. regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Measured: Week 8
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Measured: Week 8
Secondary outcomes (8)
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Mean Percent Change From Baseline in PASI Scores
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
Measured: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants in Each IGA Mod 2011 Score Category
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Measured: Baseline, weeks 8, 16, 24, 32 and 40
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Measured: Baseline, weeks 8, 16, 24, 32 and 40
Number of Participants Who Developed Anti-secukinumab Antibodies
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Measured: Baseline, weeks 12, 24 and 40
Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque-type PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412944
- Sponsor's protocol ID
- CAIN457A2307
- Other IDs
- 2011-002510-36
- Acronym
- STATURE
- Status last verified
- Mar 2015
- First submitted
- 5 Aug 2011
- Last updated
- 18 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab
- ClinicalTrials.gov ID
- NCT01412944
- Acronym / sponsor ID
- STATURE / CAIN457A2307
- Conditions
- Plaque-type Psoriasis
- Keywords
- Psoriasis, plaque, inflammatory skin disease, scaly patches, AIN457, secukinumab, Moderate to severe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Posted 18 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIN457 subcutaneous (s.c.) | Experimental | Drug: secukinumab 150mgDuring the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457. |
| AIN457 I.V. | Experimental | Drug: secukinumab 10mg/kg i.v. regimenDuring the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written Informed Consent must be obtained before any assessment is performed,
- Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
- A partial response is defined as having achieved ≥ PASI 50 but < 75 response.
Key exclusion criteria (7 listed)
- Pregnant women or lactating women
- Forms of psoriasis other than chronic plaque -type
- Ongoing use of prohibited psoriasis treatments
- Ongoing use of other non-psoriasis prohibited treatments
- Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
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 |
|---|---|---|
| secukinumab 150mgsecukinumab 150mg (2 injections per dose) | Drug | AIN457 subcutaneous (s.c.) |
| secukinumab 10mg/kg i.v. regimensecukinumab 10mg/kg i.v. regimen | Drug | AIN457 I.V. |
Primary outcome
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
Time frame: Week 8
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
Time frame: Week 8
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
8 secondary outcomes
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Mean Percent Change From Baseline in PASI Scores
Time frame: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants in Each IGA Mod 2011 Score Category
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Time frame: Baseline, weeks 8, 16, 24, 32 and 40
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
Time frame: Baseline, weeks 8, 16, 24, 32 and 40
Number of Participants Who Developed Anti-secukinumab Antibodies
Time frame: Baseline, weeks 12, 24 and 40
Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
Time frame: End of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing secukinumab 150mg and secukinumab 10mg/kg i.v. regimen in people with Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 27 sites in 8 countries.
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 7 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Germany, Japan, Austria, Canada and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI (time frame: Week 8). 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 18 Mar 2015.