PsoriasisPhase 3NCT01952015
Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
A Phase 3 study testing Secukinumab in people with Psoriasis, run by Novartis Pharmaceuticals at 10 sites in Japan.
Trial summary
The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 10 sitesJapan
- Study dates
- 21 Aug 2013to 15 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At baseline, presence of GPP classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
- At baseline, erythema area with pustule ≥ 10%
Who cannot join
- Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
- At baseline, : total score of JDA severity index for GPP ≥ 14
- Drug-induced psoriasis
- Ongoing use of prohibited psoriasis treatments.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8510
Novartis Investigative Site
Chiyoda-ku, Tokyo, 102-8798
Novartis Investigative Site
Fukuoka, Fukuoka, 814 0180
Novartis Investigative Site
Hachiōji, Tokyo, 192-0032
Novartis Investigative Site
Inashiki-gun, Ibaraki, 300-0395
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0296
Novartis Investigative Site
Kofu, Yamanashi, 400-8506
Novartis Investigative Site
Sapporo, Hokkaido, 060-0063
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
About this study
Official title: A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability in Japanese Subjects With Generalized Pustular Psoriasis
The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
- Conditions
- Psoriasis
- Being tested
- Secukinumab
- Keywords
- generalized pustular psoriasis, skin condition, skin disease,
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).
| Study group | Role | What they receive |
|---|---|---|
| AIN457 | Experimental | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.
* "No up-titration" group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
* "Up-titration" group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.
Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion. Receives: Biological: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI).
Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.
Measured: 16 weeks
Secondary outcomes (8)
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as "very much improved", "much improved", "minimally improved".
Two patients did not achieve treatment success at week 52 with CGI evaluated as "missing" and both were imputed as "no treatment success".
Measured: 52 weeks
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".
Measured: week 148
Summary of Clinical Global Impression up to End of Trial
Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened.
Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as "no treatment success".
Measured: up to week 148 (End of Trial)
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.
Measured: up to week 148 (End of Trial)
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin.
The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2.
The higher the JDA severity index for GPP score the worse the outcome.
Measured: up to week 148 (end of trial)
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL).
Percent change=100 x Absolute change/post baseline.
Measured: up to week 148 (end of trial)
Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay \& Khan 94). The measure is self-admin. \& includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute \& chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life.
Measured: Up to week 148 (end of treatment)
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at 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 posted27 Sep 2013 (estimated)
- Study start21 Aug 2013
- Primary completion15 Mar 2016
- Study completion15 Mar 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT01952015
- Sponsor's protocol ID
- CAIN457A1302
- Status last verified
- Mar 2019
- First submitted
- 24 Sep 2013
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability in Japanese Subjects With Generalized Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT01952015
- Acronym / sponsor ID
- CAIN457A1302
- Conditions
- Psoriasis
- Keywords
- generalized pustular psoriasis, skin condition, skin disease,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2013 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Posted 15 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIN457 | Experimental | Biological: SecukinumabAll subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8. * "No up-titration" group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48. * "Up-titration" group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48. Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At baseline, presence of GPP classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
- At baseline, erythema area with pustule ≥ 10%
Key exclusion criteria (4 listed)
- Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
- At baseline, : total score of JDA severity index for GPP ≥ 14
- Drug-induced psoriasis
- Ongoing use of prohibited psoriasis treatments.
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 |
|---|---|---|
| SecukinumabSecukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose). | Biological | AIN457 |
Primary outcome
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Time frame: 16 weeks
Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.
8 secondary outcomes
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Time frame: 52 weeks
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Time frame: week 148
Summary of Clinical Global Impression up to End of Trial
Time frame: up to week 148 (End of Trial)
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Time frame: up to week 148 (End of Trial)
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Time frame: up to week 148 (end of trial)
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
Time frame: up to week 148 (end of trial)
Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
Time frame: Up to week 148 (end of treatment)
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
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 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
10 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 Psoriasis, run by Novartis Pharmaceuticals at 10 sites in Japan.
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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. 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 15 Mar 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 Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) (time frame: 16 weeks). 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 15 Mar 2019.