Moderate to Severe Plaque-type PsoriasisPhase 3NCT01544595
Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
A Phase 3 study testing Secukinumab (AIN457) in people with Moderate to Severe Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 182 sites in 26 countries.
Trial summary
This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque-type Psoriasis
- What is being tested?
- Secukinumab (AIN457)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,147 participants
- Where
- 182 sitesin 26 countries
- Study dates
- 19 Jun 2012to 26 Jun 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
- Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.
- Written informed consent form.
Who cannot join
- A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.
- Ongoing use of prohibited psoriasis or non-psoriasis treatments.
- 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).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Trial locations and contacts
182 sites in 26 countries.
182 sites in 26 countries
United States37 sites
Novartis Investigative Site
Ann Arbor, Michigan, 48109
Novartis Investigative Site
Austin, Texas, 78759
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Colorado Springs, Colorado, 80915
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Dallas, Texas, 75246-1613
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Johnston, Rhode Island, 02919
Novartis Investigative Site
Kingsport, Tennessee, 37660
Novartis Investigative Site
Los Angeles, California, 90045
Novartis Investigative Site
Louisville, Kentucky, 40241
Novartis Investigative Site
Louisville, Kentucky, 40291
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
New York, New York, 10029
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Omaha, Nebraska, 68144
Novartis Investigative Site
Oregon City, Oregon, 97045
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Novartis Investigative Site
Phoenix, Arizona, 85013
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Portland, Oregon, 97223
Novartis Investigative Site
Rochester, New York, 14623
Novartis Investigative Site
Salt Lake City, Utah, 84117
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Diego, California, 92103
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Snellville, Georgia, 30078
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Warren, Ohio, 44483
Germany33 sites
Novartis Investigative Site
Augsburg, 86179
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 13187
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Bochum, 44793
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Darmstadt, 64283
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Erfurt, 99089
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Greifswald, 17475
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanau, 63450
Novartis Investigative Site
Heidelberg, 69115
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Krefeld, 47805
Novartis Investigative Site
München, 80802
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Osnabrück, 49074
Novartis Investigative Site
Plauen, 08529
Novartis Investigative Site
Recklinghausen, 45657
Novartis Investigative Site
Schwerin, 19055
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Wuppertal, 42275
Japan18 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8510
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113 8655
Novartis Investigative Site
Chiyoda-ku, Tokyo, 102-8798
Novartis Investigative Site
Fukuoka, Fukuoka, 814-0180
Novartis Investigative Site
Inashiki-gun, Ibaraki, 300-0395
Novartis Investigative Site
Isehara, Kanagawa, 259-1193
Novartis Investigative Site
Kawasaki, Kanagawa, 213-8507
Novartis Investigative Site
Kobe, Hyōgo, 654-0155
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
Novartis Investigative Site
Kyoto, Kyoto, 602-8566
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
Sagamihara, Kanagawa, 228-8522
Novartis Investigative Site
Sapporo, Hokkaido, 060-0063
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141 8625
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
Canada12 sites
Novartis Investigative Site
Edmonton, Alberta, T5K 1X3
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1Z2
Novartis Investigative Site
Hamilton, Ontario, L8N 1V6
Novartis Investigative Site
Markham, Ontario, L3P 1A8
Novartis Investigative Site
Moncton, New Brunswick, E1C 8X3
Novartis Investigative Site
Montreal, Quebec, H3H 1V4
Novartis Investigative Site
Peterborough, Ontario, K9J 5K2
Novartis Investigative Site
Richmond Hil, Ontario, L4B 1A5
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4X7
Novartis Investigative Site
Surrey, British Columbia, V3V 0C6
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E8
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
South Korea9 sites
Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Daejeon, Korea, 35015
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Seocho-gu, 06591
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05030
Novartis Investigative Site
Seoul, 156-755
France7 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Marseille, 13913
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, Cedex 10, 75475
Novartis Investigative Site
Reims, 51090
Novartis Investigative Site
Toulouse, 31400
United Kingdom7 sites
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Harrogate, HG2 7SX
Novartis Investigative Site
London, England, E11 1NR
Novartis Investigative Site
Nuneaton, CV10 7DJ
Novartis Investigative Site
Plymouth, Devon, PL6 8DH
Novartis Investigative Site
Salford, Manchester, M6 8HD
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT
Argentina6 sites
Novartis Investigative Site
Buenos Aires, C1425DKG
Novartis Investigative Site
CABA, Buenos Aires, C1062ABK
Novartis Investigative Site
CABA, Buenos Aires, C1122AAF
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH
Novartis Investigative Site
CABA, Buenos Aires, C1425BEI
Novartis Investigative Site
Mendoza, M5502EZA
Hungary6 sites
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Miskolc, 3529
Novartis Investigative Site
Szeged, H-6725
Novartis Investigative Site
Szombathely, 9700
Spain6 sites
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Santa Coloma de Gramanet, Catalonia, 08923
Novartis Investigative Site
Valencia, Valencia, 46014
Australia4 sites
Novartis Investigative Site
Carlton, Victoria, 3053
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Latvia4 sites
Novartis Investigative Site
Daugavpils, LVA, LV-5404
Novartis Investigative Site
Riga, 1012
Novartis Investigative Site
Riga, LV-1001
Novartis Investigative Site
Ventspils, LVA, LV-3601
Lithuania4 sites
Novartis Investigative Site
Kaunas, LTU, LT-50161
Novartis Investigative Site
Klaipėda, LTU, 92304
Novartis Investigative Site
Vilnius, LT-07195
Novartis Investigative Site
Vilnius, LT-08661
Poland4 sites
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Lodz, 90-436
Novartis Investigative Site
Poznan, 60 529
Novartis Investigative Site
Wroclaw, 50-368
Belgium3 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Liège, 4000
Colombia3 sites
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogotá, 110221
Estonia3 sites
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 51014
Israel3 sites
Novartis Investigative Site
Afula, 1834111
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Ramat Gan, 5265601
Taiwan3 sites
Novartis Investigative Site
Hsinchu, Taiwan
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 10002
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01015
Italy2 sites
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Modena, MO, 41124
Sweden2 sites
Novartis Investigative Site
Malmö, SE-205 02
Novartis Investigative Site
Uppsala, 751 85
About this study
Official title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Being tested
- Secukinumab (AIN457), Placebo
- Keywords
- Psoriasis, inflammatory skin disease, scaly patches, secukinumab (AIN457), Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA) mod 2011
- Medical subject headings
- Psoriasis, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab (AIN457)Drug
Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PASI 75 Responders | Placebo comparator | PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen. Receives: Drug: Secukinumab (AIN457); Drug: Placebo |
| Partial responders | Experimental | Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies. Receives: Drug: Secukinumab (AIN457) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52).
Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t.
PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.
Measured: At week 68 (16 weeks after week 52)
Secondary outcomes (21)
Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period
Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab.
PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement [reduction] in PASI score compared to baseline of the core study).
PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders.
PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders.
PASI 100 response/remission: complete clearing of psoriasis (PASI=0)
Measured: Week 52, 104, and 156
Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period
Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.
Measured: Week 52, Week 104, Week 156, week 208, week 260
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period
The improvement (decrease from baseline) in PASI total scores observed at Week 52.
Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.
Measured: Week 52, 104, and 156
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period
Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.
Measured: Week 52, Week 104, Week 156, week 208, week 260
Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period
Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions).
Patients in the placebo groups were not evaluable after re-treatment with Secukinumab
Measured: Week 52 (baseline), 104, and 156
Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period
Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)
Measured: Week 52, Week 104, Week 156, week 208, week 260
Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period
Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.
Measured: Week 52, Week 104, Week 156, week 208, week 260
Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period
Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52.
time = 0 refers to Week 52
Measured: Week 68
Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse
PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52
Measured: up to week 260
Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse
IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse.
time = 0 refers to Week 52
Measured: up to week 260
Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period
Time 0 = week 52
Measured: up to week 156
Percent of Participants With Relapse After Last Injection
Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by >50%.
Time 0 = week 52
Measured: up to week 16
Percent of Participants With Rebound After Last Injection
Rebound: PASI increases to > 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of > 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.
Measured: up to week 68
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)
Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.
Measured: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period
Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.
Measured: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period
EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
EQ-5D Health State Assessment (Observed Value) - Entire Study Period
EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: week 64, 76, 88, 104, 116, 128, 140, and 156
Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period
CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.
IR=incidence rate per 100 subject years
Measured: Week 52-156
Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period
CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.
Measured: approximately 4 years
Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period
QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.
IR=incidence rate per 100 subject years.
Measured: Week 52 - 156
Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period
QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study start19 Jun 2012
- Primary completion26 Jun 2017
- Study completion26 Jun 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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,147 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
- NCT01544595
- Sponsor's protocol ID
- CAIN457A2302E1
- Other IDs
- 2012-000533-39
- Status last verified
- Nov 2018
- First submitted
- 28 Feb 2012
- Last updated
- 20 Dec 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
Langley RG, Sofen H, Dei-Cas I, Reich K, Sigurgeirsson B, Warren RB, Paul C, Szepietowski JC, Tsai TF, Hampele I, You R, Charef P, Papavassilis C. Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials. Br J Dermatol. 2023 Feb 10;188(2):198-207. doi: 10.1093/bjd/ljac040.
PubMed 36763857
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
- ClinicalTrials.gov ID
- NCT01544595
- Acronym / sponsor ID
- CAIN457A2302E1
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Keywords
- Psoriasis, inflammatory skin disease, scaly patches, secukinumab (AIN457), Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA) mod 2011
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,147 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2012 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Posted 20 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASI 75 Responders | Placebo comparator | Drug: Secukinumab (AIN457), Drug: PlaceboPASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen. |
| Partial responders | Experimental | Drug: Secukinumab (AIN457)Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.
- Written informed consent form.
Key exclusion criteria (4 listed)
- A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.
- Ongoing use of prohibited psoriasis or non-psoriasis treatments.
- 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).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
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 (AIN457)Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions. | Drug | PASI 75 Responders, Partial responders |
| PlaceboPlacebo | Drug | PASI 75 Responders |
Primary outcome
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
Time frame: At week 68 (16 weeks after week 52)
The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.
21 secondary outcomes
Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period
Time frame: Week 52, 104, and 156
Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period
Time frame: Week 52, 104, and 156
Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period
Time frame: Week 52 (baseline), 104, and 156
Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period
Time frame: Week 52, Week 104, Week 156, week 208, week 260
Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period
Time frame: Week 68
Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse
Time frame: up to week 260
Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse
Time frame: up to week 260
Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period
Time frame: up to week 156
Percent of Participants With Relapse After Last Injection
Time frame: up to week 16
Percent of Participants With Rebound After Last Injection
Time frame: up to week 68
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)
Time frame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period
Time frame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period
Time frame: Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
EQ-5D Health State Assessment (Observed Value) - Entire Study Period
Time frame: week 64, 76, 88, 104, 116, 128, 140, and 156
Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period
Time frame: Week 52-156
Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period
Time frame: approximately 4 years
Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period
Time frame: Week 52 - 156
Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period
Time frame: Approximately 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36763857Langley RG, Sofen H, Dei-Cas I, Reich K, Sigurgeirsson B, Warren RB, Paul C, Szepietowski JC, Tsai TF, Hampele I, You R, Charef P, Papavassilis C. Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials. Br J Dermatol. 2023 Feb 10;188(2):198-207. doi: 10.1093/bjd/ljac040.
- 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
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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
182 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab (AIN457) in people with Moderate to Severe Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 182 sites in 26 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 2 inclusion and 4 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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 182 sites in United States, Germany, Japan, Canada, South Korea and 21 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. Some participants in this study may receive a placebo. 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 20 Dec 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?
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 (time frame: At week 68 (16 weeks after week 52)). 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 NCT01544595, 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 20 Dec 2018.