Moderate to Severe Plaque-type PsoriasisPhase 3GAINNCT02474069
Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis
A Phase 3 study testing Secukinumab in people with Moderate to Severe Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 89 sites in Germany.
Trial summary
This study is designed to support the optimal use of secukinumab by providing data to refine guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients who had less than almost clear skin at week… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Moderate to Severe Plaque-type Psoriasis
- What is being tested?
- Secukinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 89 sitesGermany
- Study dates
- 8 Feb 2015to 15 Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects eligible for inclusion in this study must fulfill all of the following criteria:
- Subjects must be able to understand and communicate with the investigator and must give a written, signed and dated informed consent before any study related activity is performed and who are willing and capable to comply with all study procedures.
- Men or women at least 18 years of age at time of screening.
- Chronic plaque type psoriasis diagnosed for at least 6 months prior to baseline
- Moderate to severe plaque type psoriasis at baseline derived from the European consensus (Mrowietz et al., 2011): BSA (Body Surface Area) >10% and PASI>10 and DLQI>10.
- Candidates for biologic therapy who failed to respond to, or who had a contraindication to or were intolerant to previous conventional systemic therapies.
- According to local guidelines, to exclude chest infection before initiation of a biologic immunomodulating therapy, it is necessary to have obtained an image of the chest (X-ray, computerized tomography or magnetic resonance imaging) within 12 weeks prior to screening and have this evaluated by a qualified physician.
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis).
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
- Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to.
- Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A or the IL-17A receptor (e.g. brodalumab, ixekizumab).
Show all 34Show fewer
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
- Study personnel or first degree relatives of investigator(s) must not be included in the study.
- Women who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)) who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion
- definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post- surgical bilateral oophorectomy with or without hysterectomy
- examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynakologie und Geburtshilfe:
- hormonal oral contraception (Combination of estrogen and gestagen, PI=0.1-0.9) hormonal vaginal ring (combination of estrogen and gestagen, PI=0.65 uncorr.; 0.4 corr.)
- hormonal transdermal patch (combination of estrogen and gestagen, PI= 0.72 uncorr.; 0.9 corr.)
- Estrogen-free ovulation inhibitors containing desogestrel (PI=0.14)
- Implanted hormones containing etonogestrel (PI=0-0.08)
- Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
- Intra-uterine progestine device (synthetic progestin containing IUDs,PI=0.16)
- Oral contraceptives without estrogen (e.g. "mini-pills"), nonsynthetic progesterone only IUDs, female condoms, cervical shield, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. Patients with psoriatic arthritis are not excluded.
- Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
- Subjects with preexisting or recent-onset central or peripheral nervous system demyelinating disorders at discretion of the investigator.
- Significant medical problems, including but not limited to the following: uncontrolled hypertension (≥160 systolic and/or 95 diastolic mmHg), congestive heart failure [New York Heart Association status of class III or IV].
- Subjects with a serum creatinine level exceeding 2.0 mg/dl (176.8μmol/l) at screening.
- Screening total white blood cell (WBC) count <2,500/μl, or platelets <100,000/μl or neutrophils <1,500/μl or hemoglobin <8.5 g/dl.
- Active systemic infections during the last two weeks (exception: common cold) prior to screening or any infection that reoccurs on a regular basis.
- History of an ongoing, chronic or recurrent infectious disease including recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening. Subjects with a positive or indeterminate QuantiFERON TB-Gold test may participate in the study if further full tuberculosis work up (according to local practice/guidelines) completed at least 12 weeks prior to first study drug administration establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines for at least 4 weeks prior to screening.
- Past medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to screening.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
- Inability or unwillingness to undergo repeated venipuncture (e.g. because of poor tolerability or lack of access to veins).
- Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
- History or evidence of ongoing alcohol or drug abuse, within the last six months before screening.
- Plans for administration of live vaccines during the study period or 6 weeks prior to screening.
- No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects.
Trial locations and contacts
89 sites in 1 country.
89 sites in 1 country
Germany89 sites
Novartis Investigative Site
Bad Bentheim, 48455
Novartis Investigative Site
Berlin, 10247
Novartis Investigative Site
Berlin, 10405
Novartis Investigative Site
Berlin, 10437
Novartis Investigative Site
Berlin, 10783
Novartis Investigative Site
Berlin, 12437
Novartis Investigative Site
Berlin, 13055
Novartis Investigative Site
Berlin, 13086
Novartis Investigative Site
Berlin, 13088
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Berlin, 13187
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Berlin, 13507
Novartis Investigative Site
Berlin, 14052
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Blaubeuren Abbey, 89143
Novartis Investigative Site
Blaustein, 89134
Novartis Investigative Site
Bochum, 44803
Novartis Investigative Site
Bonn, 53111
Novartis Investigative Site
Borna, 04552
Novartis Investigative Site
Cologne, 50674
Novartis Investigative Site
Darmstadt, 64283
Novartis Investigative Site
Dresden, 01097
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Duisburg, 47166
Novartis Investigative Site
Dülmen, 48249
Novartis Investigative Site
Düren, 52349
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79098
Novartis Investigative Site
Freiburg im Breisgau, 79100
Novartis Investigative Site
Freising, 85354
Novartis Investigative Site
Friedrichshafen, 88045
Novartis Investigative Site
Garching, 85748
Novartis Investigative Site
Germering, 82110
Novartis Investigative Site
Giessen, 35390
Novartis Investigative Site
Glückstadt, 25348
Novartis Investigative Site
Goslar, 38640
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Greifswald, 17475
Novartis Investigative Site
Halle, 06108
Novartis Investigative Site
Halle, 06120
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanover, 30159
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Hildesheim, 31134
Novartis Investigative Site
Ibbenbuehren, 49477
Novartis Investigative Site
Ibbenbueren, 49477
Novartis Investigative Site
Itzehoe, 25524
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kassel, 34125
Novartis Investigative Site
Kiel, 24103
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Langenau, 89129
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Lingen, 49809
Novartis Investigative Site
Löhne, 32584
Novartis Investigative Site
Lüdenscheid, D 58511
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
München, 80335
Novartis Investigative Site
München, 80469
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Münster, 48143
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Oberhausen, 46147
Novartis Investigative Site
Osnabrück, 49078
Novartis Investigative Site
Pommelsbrunn, 91224
Novartis Investigative Site
Potsdam, 14467
Novartis Investigative Site
Quedlinburg, 06484
Novartis Investigative Site
Remscheid, 42897
Novartis Investigative Site
Rheinbach, 53359
Novartis Investigative Site
Schweinfurt, 97421
Novartis Investigative Site
Soest, 59494
Novartis Investigative Site
Stade, 21682
Novartis Investigative Site
Straubing, 94315
Novartis Investigative Site
Stuttgart, 70176
Novartis Investigative Site
Stuttgart-Weilimdorf, 70499
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm, 89081
Novartis Investigative Site
Weißenfels, 06667
Novartis Investigative Site
Wiesbaden, 65199
Novartis Investigative Site
Wolfenbüttel, 38300
Novartis Investigative Site
Wuppertal, 42105
Novartis Investigative Site
Wuppertal, 42117
Novartis Investigative Site
Wuppertal, 42349
Novartis Investigative Site
Würzburg, 97080
About this study
Official title: A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of 16 Weeks Secukinumab Dosage Interval Shortening in Comparison to Continued Standard Treatment (4-weekly 300 mg s.c.) in Patients With Moderate-severe Plaque Type Psoriasis Who Achieved Less Than Almost Clear Skin After 16 Weeks Under the Standard Dose of Secukinumab
This study is designed to support the optimal use of secukinumab by providing data to refine guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients who had less than almost clear skin at week 16.
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Being tested
- Secukinumab
- Keywords
- skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing psoriasis, remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching, auto-immune, plaque-type psoriasis, plaque
- Medical subject headings
- Skin Diseases, Plaque, Amyloid, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab Interval Shortening | Active comparator | Not described Receives: Drug: Secukinumab |
| Secukinumab 4-weekly | Active comparator | Not described Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With PASI 90 Response at Week 32
Number of participants with at least 90% 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).
Measured: at 32 weeks
Number of Participants With PASI 90 Response at Week 32 for PPS
Number of participants with at least 90% 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).
Measured: at week 32
Secondary outcomes (10)
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100
Number of participants with at least 50, 75, 90 or 100% 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).
Measured: at weeks 1, 2, 3, 4, 8, 12 and 16
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100
Number of participants with at least 90 or 100% 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).
Measured: at weeks 18, 22, 30, 32
Selection Phase:Summary of PASI Total Score
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: at weeks 1,2,3,4,8, 12, 16
Comparative Dose Phase: Summary of PASI Total Score
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: Weeks 18, 22, 26, 30 and 32
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP
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.
The DLQI was designed to assess health-related quality of life (HRQoL) in adult patients with skin diseases including psoriasis.
Measured: Weeks 4, 16, 18, 22, 26, 30, 32
Number of Patients Achieving DLQI Total Score <= 5 in the CDP
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.
Measured: Weeks 4, 16, 18, 22, 26, 30, 32
Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1
The IGA 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, 4 = severe and 5 = very severe.
Measured: Weeks 4, 16
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1
The IGA 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, 4 = severe and 5 = very severe.
Measured: Weeks 18, 22, 26, 30, 32
Selection Phase: Summary of IGA Score
The IGA 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, 4 = severe and 5 = very severe.
Measured: Weeks 4, 16
Comparative Dose Phase:Summary of IGA Score
The IGA 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, 4 = severe and 5 = very severe.
Measured: Weeks 18, 22, 26, 30, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start8 Feb 2015
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
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 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
- Model description
- This was a multicenter, double-blind, randomized study in 772 patients with moderate to severe chronic plaque-type psoriasis. Patients were enrolled at 89 study sites in Germany. The study was divided into 3 phases: screening, selection phase (SP), and comparative dosing phase (CDP). In the screening phase, inclusion and exclusion criteria were confirmed. Eligible patients rolled over into a selection phase (SP) where all patients received 300 mg s.c. open-label secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16, PASI response was assessed as a basis for further treatment: 300 mg s.c. secukinumab treatment every 4 weeks vesus 300 mg s.c. secukinumab treatment every 2 weeks. Patients who achieved at least clear or almost clear skin (≥ PASI 90) at Week 16 discontinued the study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474069
- Sponsor's protocol ID
- CAIN457ADE04
- Other IDs
- 2014-001974-32, 2014
- Acronym
- GAIN
- Status last verified
- Apr 2019
- First submitted
- 26 Feb 2015
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of 16 Weeks Secukinumab Dosage Interval Shortening in Comparison to Continued Standard Treatment (4-weekly 300 mg s.c.) in Patients With Moderate-severe Plaque Type Psoriasis Who Achieved Less Than Almost Clear Skin After 16 Weeks Under the Standard Dose of Secukinumab
- ClinicalTrials.gov ID
- NCT02474069
- Acronym / sponsor ID
- GAIN / CAIN457ADE04
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Keywords
- skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing psoriasis, remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to support the optimal use of secukinumab by providing data to refine guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients who had less than almost clear skin at week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a multicenter, double-blind, randomized study in 772 patients with moderate to severe chronic plaque-type psoriasis. Patients were enrolled at 89 study sites in Germany. The study was divided into 3 phases: screening, selection phase (SP), and comparative dosing phase (CDP). In the screening phase, inclusion and exclusion criteria were confirmed. Eligible patients rolled over into a selection phase (SP) where all patients received 300 mg s.c. open-label secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16, PASI response was assessed as a basis for further treatment: 300 mg s.c. secukinumab treatment every 4 weeks vesus 300 mg s.c. secukinumab treatment every 2 weeks. Patients who achieved at least clear or almost clear skin (≥ PASI 90) at Week 16 discontinued the study
| Arm | Type | Receives |
|---|---|---|
| Secukinumab Interval Shortening | Active comparator | Drug: Secukinumab |
| Secukinumab 4-weekly | Active comparator | Drug: Secukinumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be able to understand and communicate with the investigator and must give a written, signed and dated informed consent before any study related activity is performed and who are willing and capable to comply with all study procedures.
- Men or women at least 18 years of age at time of screening.
- Chronic plaque type psoriasis diagnosed for at least 6 months prior to baseline
- Moderate to severe plaque type psoriasis at baseline derived from the European consensus (Mrowietz et al., 2011): BSA (Body Surface Area) >10% and PASI>10 and DLQI>10.
- Candidates for biologic therapy who failed to respond to, or who had a contraindication to or were intolerant to previous conventional systemic therapies.
Key exclusion criteria (34 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis).
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
- Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to.
- Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
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 | Drug | Secukinumab 4-weekly, Secukinumab Interval Shortening |
Primary outcome
Number of Participants With PASI 90 Response at Week 32
Time frame: at 32 weeks
Number of participants with at least 90% 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).
Number of Participants With PASI 90 Response at Week 32 for PPS
Time frame: at week 32
Number of participants with at least 90% 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).
10 secondary outcomes
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100
Time frame: at weeks 1, 2, 3, 4, 8, 12 and 16
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100
Time frame: at weeks 18, 22, 30, 32
Selection Phase:Summary of PASI Total Score
Time frame: at weeks 1,2,3,4,8, 12, 16
Comparative Dose Phase: Summary of PASI Total Score
Time frame: Weeks 18, 22, 26, 30 and 32
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP
Time frame: Weeks 4, 16, 18, 22, 26, 30, 32
Number of Patients Achieving DLQI Total Score <= 5 in the CDP
Time frame: Weeks 4, 16, 18, 22, 26, 30, 32
Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1
Time frame: Weeks 4, 16
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1
Time frame: Weeks 18, 22, 26, 30, 32
Selection Phase: Summary of IGA Score
Time frame: Weeks 4, 16
Comparative Dose Phase:Summary of IGA Score
Time frame: Weeks 18, 22, 26, 30, 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Related trials for Moderate to Severe Plaque-type Psoriasis
Not yet recruitingPhase 2/3
A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis
Moderate to Severe Plaque Psoriasis
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.
The record lists no contact. Use the official record to reach the sponsor.
89 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab in people with Moderate to Severe Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 89 sites in Germany.
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 7 inclusion and 34 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Germany. 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 5 Jul 2019). 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?
Number of Participants With PASI 90 Response at Week 32 (time frame: at 32 weeks). 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 5 Jul 2019.