PsoriasisPhase 3ALLURENCT02748863
Study of Secukinumab With 2 mL Pre-filled Syringes
A Phase 3 study testing Secukinumab 2 mL form and Secukinumab 1 mL form in people with Psoriasis, run by Novartis Pharmaceuticals at 52 sites in 11 countries.
Trial summary
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Secukinumab 2 mL form and Secukinumab 1 mL form
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 52 sitesin 11 countries
- Study dates
- 12 Dec 2016to 8 Jun 2018
- 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 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 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 study consent according to local laws and regulations.
- Men or women of at least 18 years of age at the time of Screening.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
- Moderate to severe psoriasis as defined at Randomization by:
- PASI score of 12 or greater, and
Show all 12Show fewer
- IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
- Topical treatment and/or
- Phototherapy and/or
- Previous systemic therapy
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
- Ongoing use of prohibited treatments. Washout periods detailed in the protocol 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 will be considered not eligible for this study since UV light exposure is prohibited.
- Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- 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.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for 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).
- History of hypersensitivity to any of study drug constituent
Trial locations and contacts
52 sites in 11 countries.
52 sites in 11 countries
United States15 sites
Novartis Investigative Site
Fountain Valley, California, 92708
Novartis Investigative Site
Fremont, California, 95438
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Marietta, Georgia, 30060
Novartis Investigative Site
Miami, Florida, 33155
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Portland, Oregon, 97223
Novartis Investigative Site
Saint Joseph, Missouri, 64506
Novartis Investigative Site
San Antonio, Texas, 78218
Novartis Investigative Site
Savannah, Georgia, 31406
Novartis Investigative Site
Sugar Land, Texas, 77479
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Verona, New Jersey, 07044
Spain8 sites
Novartis Investigative Site
Bilbao, Bizkaia, 48013
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Pontevedra, 36003
Novartis Investigative Site
Salamanca, Castille and León, 37007
Novartis Investigative Site
Sant Joan Despí, Barcelona, 08970
Novartis Investigative Site
Valencia, Valencia, 46026
Latvia6 sites
Novartis Investigative Site
Daugavpils, LVA, LV-5404
Novartis Investigative Site
Jelgava, LVA, LV-3001
Novartis Investigative Site
Riga, LVA, LV-1003
Novartis Investigative Site
Riga, 1012
Novartis Investigative Site
Riga, LV-1001
Novartis Investigative Site
Ventspils, LVA, LV-3601
Germany5 sites
Novartis Investigative Site
Berlin, 10629
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
München, 80337
Russia5 sites
Novartis Investigative Site
Chelyabinsk, 454092
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 107076
Novartis Investigative Site
Saint Petersburg, 191123
Novartis Investigative Site
Saint Petersburg, 194021
United Kingdom4 sites
Novartis Investigative Site
Cambridge, CB7 5JD
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Dundee, DD1 9SY
Novartis Investigative Site
Surrey, RH1 5RH
Belgium2 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Liège, 4000
Canada2 sites
Novartis Investigative Site
Edmonton, Alberta, T5K 1X3
Novartis Investigative Site
Surrey, British Columbia, V3R 6A7
Poland2 sites
Novartis Investigative Site
Olsztyn, 10-045
Novartis Investigative Site
Warsaw, 02-507
Turkey (Türkiye)2 sites
Novartis Investigative Site
Bursa, 16059
Novartis Investigative Site
Izmir, 35040
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
Read the detailed description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.
- Conditions
- Psoriasis
- Being tested
- Placebo, Secukinumab 2 mL form, Secukinumab 1 mL form
- Keywords
- psoriasis, secukinumab, pre-filled syringes
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
Secukinumab 2 mL formDrug
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Secukinumab 1 mL formDrug
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe Receives: Drug: Placebo |
| Secukinumab 2 mL form | Experimental | Secukinumab 300 mg, provided in a 2 mL pre-filled syringe Receives: Drug: Secukinumab 2 mL form |
| Secukinumab 1 mL form | Active comparator | Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form) Receives: Drug: Secukinumab 1 mL form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
Number of participants who achieved ≥ 75% reduction in PASI compared to 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: 12 weeks
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Measured: 12 weeks
Secondary outcomes (3)
Participants With PASI 90 After 12 Weeks of Treatment
Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline
Measured: 12 weeks
Number of Participants With PASI 100 Response After 12 Weeks of Treatment
Participants who achieved 100% reduction in PASI compared to baseline
Measured: 12 weeks
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Measured: up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start12 Dec 2016
- Primary completion8 Aug 2017
- Study completion8 Jun 2018
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 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
- NCT02748863
- Sponsor's protocol ID
- CAIN457A2323
- Acronym
- ALLURE
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2016
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Sigurgeirsson B, Schakel K, Hong CH, Effendy I, Placek W, Rich P, Keefe D, Bruin G, Charef P, Fu R, Hampele I, Patekar M. Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study. J Dermatolog Treat. 2022 May;33(3):1718-1726. doi: 10.1080/09546634.2021.1902925. Epub 2021 Apr 26.
PubMed 33896356
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02748863
- Acronym / sponsor ID
- ALLURE / CAIN457A2323
- Conditions
- Psoriasis
- Keywords
- psoriasis, secukinumab, pre-filled syringes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 26 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
Detailed description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe |
| Secukinumab 2 mL form | Experimental | Drug: Secukinumab 2 mL formSecukinumab 300 mg, provided in a 2 mL pre-filled syringe |
| Secukinumab 1 mL form | Active comparator | Drug: Secukinumab 1 mL formSecukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 study consent according to local laws and regulations.
- Men or women of at least 18 years of age at the time of Screening.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
- Moderate to severe psoriasis as defined at Randomization by:
- Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
Key exclusion criteria (8 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
- Ongoing use of prohibited treatments. Washout periods detailed in the protocol 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 will be considered not eligible for this study since UV light exposure is prohibited.
- Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
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 |
|---|---|---|
| Placebo2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48 | Drug | Placebo |
| Secukinumab 2 mL formSecukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48 | Drug | Secukinumab 2 mL form |
| Secukinumab 1 mL formSecukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48 | Drug | Secukinumab 1 mL form |
Primary outcome
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
Time frame: 12 weeks
Number of participants who achieved ≥ 75% reduction in PASI compared to 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).
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
Time frame: 12 weeks
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
3 secondary outcomes
Participants With PASI 90 After 12 Weeks of Treatment
Time frame: 12 weeks
Number of Participants With PASI 100 Response After 12 Weeks of Treatment
Time frame: 12 weeks
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Time frame: up to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33896356Sigurgeirsson B, Schakel K, Hong CH, Effendy I, Placek W, Rich P, Keefe D, Bruin G, Charef P, Fu R, Hampele I, Patekar M. Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study. J Dermatolog Treat. 2022 May;33(3):1718-1726. doi: 10.1080/09546634.2021.1902925. Epub 2021 Apr 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab 2 mL form and Secukinumab 1 mL form in people with Psoriasis, run by Novartis Pharmaceuticals at 52 sites in 11 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 12 inclusion and 8 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 15 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 52 sites in United States, Spain, Latvia, Germany, Russia and 6 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 26 Jun 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?
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (time frame: 12 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?
On the ClinicalTrials.gov record for NCT02748863, 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 15 Jul 2019.