Moderate to Severe Chronic Plaque-Type PsoriasisPhase 3NCT01640951
4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
A Phase 3 study testing AIN457 150 mg and AIN457 300 mg in people with Moderate to Severe Chronic Plaque-Type Psoriasis, run by Novartis Pharmaceuticals at 111 sites in 15 countries.
Trial summary
CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Plaque-Type Psoriasis
- What is being tested?
- AIN457 150 mg and AIN457 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 111 sitesin 15 countries
- Study dates
- 16 Sep 2012to 4 May 2017
- 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
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.
- Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307
- Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator
Who cannot join
- A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject
- Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.
- Subjects expected to be exposed to an undue safety risk if participating in the trial
- Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial
- Plans for administration of live vaccines during the study period
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).
Trial locations and contacts
111 sites in 15 countries.
111 sites in 15 countries
United States28 sites
Novartis Investigative Site
Anderson, South Carolina, 29621
Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Champaign, Illinois, 61820
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Fresno, California, 93710
Novartis Investigative Site
Fridley, Minnesota, 55432
Novartis Investigative Site
Goodlettsville, Tennessee, 37072-2301
Novartis Investigative Site
Greensboro, North Carolina, 27401
Novartis Investigative Site
Greer, South Carolina, 29651
Novartis Investigative Site
Henderson, Nevada, 89052
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Jacksonville, Florida, 32204
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Las Vegas, Nevada, 89119
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
Overland Park, Kansas, 66215
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Salt Lake City, Utah, 84124
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Francisco, California, 94118
Novartis Investigative Site
Skokie, Illinois, 60077
Novartis Investigative Site
South Miami, Florida, 33143
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
Verona, New Jersey, 07044
Novartis Investigative Site
West Palm Beach, Florida, 33409
Novartis Investigative Site
Winston-Salem, North Carolina, 27103
Germany20 sites
Novartis Investigative Site
Bad Wildbad, 75323
Novartis Investigative Site
Bochum, 44793
Novartis Investigative Site
Buchholz I. D. Nordheide, 21244
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Dippoldiswalde-Schmiedeberg, 01744
Novartis Investigative Site
Duisburg, 47166
Novartis Investigative Site
Düsseldorf, D-40225
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79104
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mahlow, 15831
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Wuppertal, 42103
Japan15 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8510
Novartis Investigative Site
Chiyoda-ku, Tokyo, 102-8798
Novartis Investigative Site
Fukuoka, Fukuoka, 815-8588
Novartis Investigative Site
Hachiōji, Tokyo, 193-0944
Novartis Investigative Site
Kisarazu, Chiba, 292-8535
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0296
Novartis Investigative Site
Maebashi, Gunma, 371 8511
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Osaka, Osaka, 550-0012
Novartis Investigative Site
Sapporo, Hokkaido, 060-0033
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Czechia6 sites
Novartis Investigative Site
Brno-Bohunice, Czech Republic, 625 00
Novartis Investigative Site
České Budějovice, 370 01
Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Nový Jičín, 741 01
Novartis Investigative Site
Prague, CZE, 180 81
Novartis Investigative Site
Prague, 100 34
Bulgaria5 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, 1231
Novartis Investigative Site
Sofia, 1404
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Varna, 9010
Canada5 sites
Novartis Investigative Site
Barrie, Ontario, L4M 6L2
Novartis Investigative Site
Montreal, Quebec, H2K 4L5
Novartis Investigative Site
Oakville, Ontario, L6J 7W5
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Novartis Investigative Site
Windsor, Ontario, N8W 1E6
France5 sites
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Pierre-Bénite, 69495
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Toulouse, 31400
Slovakia5 sites
Novartis Investigative Site
Košice, Slovak Republic, 040 15
Novartis Investigative Site
Košice, 04011
Novartis Investigative Site
Poprad, 05845
Novartis Investigative Site
Svidník, 089 01
Novartis Investigative Site
Žilina, 01207
United Kingdom5 sites
Novartis Investigative Site
Birmingham, B15 2WB
Novartis Investigative Site
Blackpool, FY3 7EN
Novartis Investigative Site
Leicester, LE7 5WW
Novartis Investigative Site
Leytonstone, London, E11 1NR
Novartis Investigative Site
Poole, BH15 2JB
Italy4 sites
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00144
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Verona, VR, 37126
Vietnam4 sites
Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Hanoi, 1000
Novartis Investigative Site
Ho Chi Minh City, VNM, 700000
Novartis Investigative Site
Ho Chi Minh City, 7000
Poland3 sites
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Poznan, 60 529
Novartis Investigative Site
Wroclaw, 50-368
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zurich, 8091
Singapore2 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 308205
About this study
Official title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.
- Being tested
- AIN457 150 mg, AIN457 300 mg, Placebo
- Keywords
- Psoriasis, Plaque, Inflammatory skin disease, Scaly patches, AIN457, Secukinumab, Moderate to Severe Plaque-type Psoriasis
- 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.
AIN457 150 mgDrug
Also called Secukinumab 150 mg
(1 injection per dose) and placebo to Secukinumab 150 mg
AIN457 300 mgDrug
Also called Secukinumab 300 mg
Secukinumab 150 mg (2 injections per dose)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AIN457 150 mg - Fixed Interval (FI) | Experimental | 1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks Receives: Drug: AIN457 150 mg; Drug: Placebo |
| AIN457 150 mg - Start of relapse (SoR) | Experimental | Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks
Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks Receives: Drug: AIN457 150 mg; Drug: Placebo |
| AIN457 300 mg - Fixed Interval (FI) | Experimental | 2 s.c. Secukinumab 150 mg PFS injections every 4 weeks Receives: Drug: AIN457 300 mg |
| AIN457 300 mg - Start of Relapse (SoR) | Experimental | Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks
Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks Receives: Drug: AIN457 300 mg; Drug: Placebo |
| AIN457 300 mg - Open Label (OL) | Experimental | Open Label - Secukinumab 300mg every 4 weeks Receives: Drug: AIN457 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Safety and Tolerability of Secukinumab
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)
Measured: Week 268
Secondary outcomes (10)
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260
PASI: 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 52, Week 104, Week 156, Week 208, Week 260
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260
PASI: 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 52, Week 104, Week 156, Week 208, Week 260
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260
PASI: 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: Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.
Measured: Week 52, Week 104, Week 156, Week 208, Week 260
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Measured: Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Measured: Week 52, Week 104, Week 156, Week 208, Week 260
EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Measured: Baseline, Week 52, Week 104, Week 156
Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.
Measured: Week 268
Percentage of Patients With Experiencing a Relapse
Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline.
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: Week 260
Percentage of Patients With Experiencing a Rebound
Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).
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: Up to Week 264 (8 weeks post last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start16 Sep 2012
- Primary completion4 May 2017
- Study completion4 May 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Chronic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 675 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
- NCT01640951
- Sponsor's protocol ID
- CAIN457A2304E1
- Other IDs
- 2012-000985-39
- Status last verified
- Apr 2018
- First submitted
- 12 Jul 2012
- Last updated
- 25 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.
PubMed 28580579
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
- ClinicalTrials.gov ID
- NCT01640951
- Acronym / sponsor ID
- CAIN457A2304E1
- Keywords
- Psoriasis, Plaque, Inflammatory skin disease, Scaly patches, AIN457, Secukinumab, Moderate to Severe Plaque-type Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2012 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 25 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AIN457 150 mg - Fixed Interval (FI) | Experimental | Drug: AIN457 150 mg, Drug: Placebo1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks |
| AIN457 150 mg - Start of relapse (SoR) | Experimental | Drug: AIN457 150 mg, Drug: PlaceboStart of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks |
| AIN457 300 mg - Fixed Interval (FI) | Experimental | Drug: AIN457 300 mg2 s.c. Secukinumab 150 mg PFS injections every 4 weeks |
| AIN457 300 mg - Start of Relapse (SoR) | Experimental | Drug: AIN457 300 mg, Drug: PlaceboStart of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks |
| AIN457 300 mg - Open Label (OL) | Experimental | Drug: AIN457 300 mgOpen Label - Secukinumab 300mg every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.
- Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307
- Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator
Key exclusion criteria (6 listed)
- A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject
- Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.
- Subjects expected to be exposed to an undue safety risk if participating in the trial
- Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial
- Plans for administration of live vaccines during the study period
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 |
|---|---|---|
| AIN457 150 mgAlso: Secukinumab 150 mg(1 injection per dose) and placebo to Secukinumab 150 mg | Drug | AIN457 150 mg - Fixed Interval (FI), AIN457 150 mg - Start of relapse (SoR) |
| AIN457 300 mgAlso: Secukinumab 300 mgSecukinumab 150 mg (2 injections per dose) | Drug | AIN457 300 mg - Fixed Interval (FI), AIN457 300 mg - Open Label (OL), AIN457 300 mg - Start of Relapse (SoR) |
| Placebo | Drug | AIN457 150 mg - Fixed Interval (FI), AIN457 150 mg - Start of relapse (SoR), AIN457 300 mg - Start of Relapse (SoR) |
Primary outcome
Long-term Safety and Tolerability of Secukinumab
Time frame: Week 268
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)
10 secondary outcomes
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260
Time frame: Week 52, Week 104, Week 156, Week 208, Week 260
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260
Time frame: Week 52, Week 104, Week 156, Week 208, Week 260
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260
Time frame: Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260
Time frame: Week 52, Week 104, Week 156, Week 208, Week 260
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260
Time frame: Baseline, Week 52, Week 104, Week 156, Week 208, Week 260
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260
Time frame: Week 52, Week 104, Week 156, Week 208, Week 260
EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156
Time frame: Baseline, Week 52, Week 104, Week 156
Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)
Time frame: Week 268
Percentage of Patients With Experiencing a Relapse
Time frame: Week 260
Percentage of Patients With Experiencing a Rebound
Time frame: Up to Week 264 (8 weeks post last dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28580579Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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
111 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AIN457 150 mg and AIN457 300 mg in people with Moderate to Severe Chronic Plaque-Type Psoriasis, run by Novartis Pharmaceuticals at 111 sites in 15 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 3 inclusion and 6 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 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, Germany, Japan, Czechia, Bulgaria and 10 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 25 May 2018). 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?
Long-term Safety and Tolerability of Secukinumab (time frame: Week 268). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01640951, which also lists 1 linked publication.
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 25 May 2018.