Plaque PsoriasisPhase 3MATURENCT03589885
Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Secukinumab 2 mL auto-injector and Secukinumab 1 mL prefilled syringe in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 22 sites in 6 countries.
Trial summary
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Secukinumab 2 mL auto-injector and Secukinumab 1 mL prefilled syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 19 Dec 2018to 5 Aug 2020
- 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 have fulfilled all of the following criteria:
- Men or Women of at least 18 years of age at time of Screening
- Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.
- 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 had 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 were considered not eligible for this study since UV light exposure was prohibited.
- Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was 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 had returned to baseline, whichever is longer; or longer if required by local regulations.
- Pregnant or nursing (lactating) women, where pregnancy was 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 was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had 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
22 sites in 6 countries.
22 sites in 6 countries
United States8 sites
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Marietta, Georgia, 30060
Novartis Investigative Site
Miami, Florida, 33155
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Saint Joseph, Missouri, 64506
Novartis Investigative Site
San Antonio, Texas, 78218
Novartis Investigative Site
Sugar Land, Texas, 77479
Novartis Investigative Site
Verona, New Jersey, 07044
Spain5 sites
Novartis Investigative Site
Alicante, Valencia, 03010
Novartis Investigative Site
Barcelona, 08003
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Valencia, Valencia, 46014
Germany4 sites
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Vechta, 49377
Novartis Investigative Site
Witten, 58453
Canada2 sites
Novartis Investigative Site
Edmonton, Alberta, T5K 1X3
Novartis Investigative Site
Surrey, British Columbia, V3R 6A7
Poland2 sites
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Wroclaw, 50-566
About this study
Official title: Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis
Read the detailed description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
- Conditions
- Plaque Psoriasis
- Being tested
- Placebo 2 mL auto-injector, Placebo 1 mL prefilled syringe, Secukinumab 2 mL auto-injector, Secukinumab 1 mL prefilled syringe
- Keywords
- Plaque psoriasis, auto-injector, 2 mL injection, secukinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo 2 mL auto-injectorDrug
Also called Placebo
All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.
PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.
PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
Placebo 1 mL prefilled syringeDrug
Also called Placebo
All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.
PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.
PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
Secukinumab 2 mL auto-injectorDrug
2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48
Secukinumab 1 mL prefilled syringeDrug
2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
| Study group | Role | What they receive |
|---|---|---|
| Placebo 2 mL auto-injector | Placebo comparator | Placebo to secukinumab s.c., provided in 2 mL auto-injector form Receives: Drug: Placebo 2 mL auto-injector |
| Placebo 1 mL prefilled syringe | Placebo comparator | Placebo to secukinumab s.c., provided in 2 * 1 ml prefilled syringe form Receives: Drug: Placebo 1 mL prefilled syringe |
| Secukinumab 2 mL auto-injector | Experimental | Secukinumab 300 mg provided in 2 mL auto-injector form Receives: Drug: Secukinumab 2 mL auto-injector |
| Secukinumab 1 mL prefilled syringe | Active comparator | Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL Receives: Drug: Secukinumab 1 mL prefilled syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI 75 Response After 12 Weeks of Treatment
Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Measured: 12 weeks
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
Measured: 12 weeks
Secondary outcomes (4)
PASI 90 Response
Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline
Measured: 12 weeks
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response
Percentage of participants who achieve ≥ 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 at each visit up to 52 weeks
Measured: 52 weeks
Successful Self-injection
Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience).
Measured: From randomization until Week 28
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Measured: Change from Baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start19 Dec 2018
- Primary completion19 Nov 2019
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque 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
- A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 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
- NCT03589885
- Sponsor's protocol ID
- CAIN457A2325
- Acronym
- MATURE
- Status last verified
- Oct 2021
- First submitted
- 5 Jul 2018
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03589885
- Acronym / sponsor ID
- MATURE / CAIN457A2325
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque psoriasis, auto-injector, 2 mL injection, secukinumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Posted 26 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis
Detailed description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 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
- 4
- Model description
- A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
| Arm | Type | Receives |
|---|---|---|
| Placebo 2 mL auto-injector | Placebo comparator | Drug: Placebo 2 mL auto-injectorPlacebo to secukinumab s.c., provided in 2 mL auto-injector form |
| Placebo 1 mL prefilled syringe | Placebo comparator | Drug: Placebo 1 mL prefilled syringePlacebo to secukinumab s.c., provided in 2 * 1 ml prefilled syringe form |
| Secukinumab 2 mL auto-injector | Experimental | Drug: Secukinumab 2 mL auto-injectorSecukinumab 300 mg provided in 2 mL auto-injector form |
| Secukinumab 1 mL prefilled syringe | Active comparator | Drug: Secukinumab 1 mL prefilled syringeSecukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL |
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 eligible for inclusion in this study must have fulfilled all of the following criteria:
- Men or Women of at least 18 years of age at time of Screening
- Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
- Moderate to severe psoriasis as defined at Randomization 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 had 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 were considered not eligible for this study since UV light exposure was prohibited.
- Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was 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 had 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 |
|---|---|---|
| Placebo 2 mL auto-injectorAlso: PlaceboAll Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 | Drug | Placebo 2 mL auto-injector |
| Placebo 1 mL prefilled syringeAlso: PlaceboAll Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 | Drug | Placebo 1 mL prefilled syringe |
| Secukinumab 2 mL auto-injector2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48 | Drug | Secukinumab 2 mL auto-injector |
| Secukinumab 1 mL prefilled syringe2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 | Drug | Secukinumab 1 mL prefilled syringe |
Primary outcome
PASI 75 Response After 12 Weeks of Treatment
Time frame: 12 weeks
Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
Time frame: 12 weeks
Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
4 secondary outcomes
PASI 90 Response
Time frame: 12 weeks
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response
Time frame: 52 weeks
Successful Self-injection
Time frame: From randomization until Week 28
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)
Time frame: Change from Baseline up to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
22 sites in 6 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 auto-injector and Secukinumab 1 mL prefilled syringe in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 22 sites in 6 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, Germany, Canada, Poland and 1 more country. 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 Aug 2021). 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?
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?
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 11 Oct 2021.