Palmoplantar Pustular PsoriasisPhase 3NCT02008890
Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
A Phase 3 study testing Secukinumab 300mg and Secukinumab 150mg in people with Palmoplantar Pustular Psoriasis, run by Novartis Pharmaceuticals at 68 sites in 10 countries.
Trial summary
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantar Pustular Psoriasis
- What is being tested?
- Secukinumab 300mg and Secukinumab 150mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 68 sitesin 10 countries
- Study dates
- 26 Dec 2013to 31 May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Palmoplantar pustular psoriasis for at least 6 months before Randomization
- Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:
- ppPASI score of ≥ 12 and
- DLQI ≥ 10
- Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:
- Topical treatment, and/or
- Phototherapy, and/or
- Previous systemic therapy
Who cannot join
- Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
- Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
- Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
- Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
- Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
Show all 9Show fewer
- Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
- Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
68 sites in 10 countries.
68 sites in 10 countries
Germany18 sites
Novartis Investigative Site
Berlin, 10827
Novartis Investigative Site
Bochum, 44803
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Düsseldorf, D 40225
Novartis Investigative Site
Freiburg im Breisgau, 79104
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Greifswald, 17475
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanau, 63450
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mahlow, 15831
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Plauen, 08529
Novartis Investigative Site
Recklinghausen, 45657
Novartis Investigative Site
Schwerin, 19055
France10 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Toulouse, 31400
United Kingdom10 sites
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Dundee, Perthshire, DD1 9SY
Novartis Investigative Site
Glasgow, G11 6NT
Novartis Investigative Site
Leytonstone, London, E11 1NR
Novartis Investigative Site
Liverpool, L14 3PE
Novartis Investigative Site
Newport, NP20 4SZ
Novartis Investigative Site
Portsmouth, PO6 6AD
Novartis Investigative Site
Salford, Manchester, M6 8HD
Novartis Investigative Site
Wolverhampton, WV10 0QP
Novartis Investigative Site
York, YO31 8HE
Spain6 sites
Novartis Investigative Site
A Coruña, 15001
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Novartis Investigative Site
Valencia, Valencia, 46014
Austria5 sites
Novartis Investigative Site
Feldkirch, A-6807
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Linz, A-4020
Novartis Investigative Site
Vienna, 1090
Novartis Investigative Site
Vienna, A-1090
Sweden5 sites
Novartis Investigative Site
Gothenburg, Västra Götaland County, SE-413 45
Novartis Investigative Site
Jönköping, 551 85
Novartis Investigative Site
Malmö, SE-205 02
Novartis Investigative Site
Stockholm, 171 76
Novartis Investigative Site
Uppsala, 751 85
Belgium4 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Poland4 sites
Novartis Investigative Site
Bydgoszcz, 85-094
Novartis Investigative Site
Gdansk, 80-803
Novartis Investigative Site
Olsztyn, 10-045
Novartis Investigative Site
Zabrze, 41-800
Russia4 sites
Novartis Investigative Site
Moscow, 107076
Novartis Investigative Site
Rostov on Don Region, 346880
Novartis Investigative Site
Ryazan, 390046
Novartis Investigative Site
Saratov, 410012
Italy2 sites
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Brescia, BS, 25123
About this study
Official title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
- Conditions
- Palmoplantar Pustular Psoriasis
- Being tested
- Secukinumab 300mg, Secukinumab 150mg, Placebo
- Keywords
- palmoplantar, pustular, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 300mgBiological
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
Secukinumab 150mgBiological
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
PlaceboBiological
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 300mg | Experimental | Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148. Receives: Biological: Secukinumab 300mg; Biological: Placebo |
| Secukinumab 150mg | Experimental | Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148. Receives: Biological: Secukinumab 150mg; Biological: Placebo |
| Placebo | Placebo comparator | Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148. Receives: Biological: Secukinumab 300mg; Biological: Secukinumab 150mg; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Measured: Baseline to Week 16
Secondary outcomes (7)
ppPASI: Absolute Change From Baseline to Week 16
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Measured: Baseline to Week 16
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Measured: Baseline to Week 16
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Measured: Week 16 to Week 52
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Measured: Week 52 to Week 148
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Measured: Baseline to Week 16 (Period 1)
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Measured: Week 16 to Week 52 (Period 2)
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Measured: Week 52 to Week 148 (extension period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start26 Dec 2013
- Primary completion24 Nov 2014
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Palmoplantar Pustular PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 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
- NCT02008890
- Sponsor's protocol ID
- CAIN457A3301
- Other IDs
- 2013-003086-34
- Status last verified
- Jan 2019
- First submitted
- 8 Dec 2013
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
- ClinicalTrials.gov ID
- NCT02008890
- Acronym / sponsor ID
- CAIN457A3301
- Conditions
- Palmoplantar Pustular Psoriasis
- Keywords
- palmoplantar, pustular, psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2013 (actual)
- Primary completion
- 24 Nov 2014 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 4 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 300mg | Experimental | Biological: Secukinumab 300mg, Biological: PlaceboSecukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148. |
| Secukinumab 150mg | Experimental | Biological: Secukinumab 150mg, Biological: PlaceboSecukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148. |
| Placebo | Placebo comparator | Biological: Secukinumab 300mg, Biological: Secukinumab 150mg, Biological: PlaceboPlacebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Palmoplantar pustular psoriasis for at least 6 months before Randomization
- Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:
- Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:
Key exclusion criteria (9 listed)
- Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
- Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
- Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
- Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
- Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
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 300mgSecukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered | Biological | Placebo, Secukinumab 300mg |
| Secukinumab 150mgsecukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered | Biological | Placebo, Secukinumab 150mg |
| Placebosecukinumab placebo s.c. (two PFS injections of placebo) self-administered | Biological | Placebo, Secukinumab 150mg, Secukinumab 300mg |
Primary outcome
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
Time frame: Baseline to Week 16
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
7 secondary outcomes
ppPASI: Absolute Change From Baseline to Week 16
Time frame: Baseline to Week 16
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Time frame: Baseline to Week 16
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Time frame: Week 16 to Week 52
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Time frame: Week 52 to Week 148
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Time frame: Baseline to Week 16 (Period 1)
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Time frame: Week 16 to Week 52 (Period 2)
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Time frame: Week 52 to Week 148 (extension period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 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 Palmoplantar Pustular Psoriasis
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Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
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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
68 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab 300mg and Secukinumab 150mg in people with Palmoplantar Pustular Psoriasis, run by Novartis Pharmaceuticals at 68 sites in 10 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 8 inclusion and 9 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 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany, France, United Kingdom, Spain, Austria and 5 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 4 Jan 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?
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) (time frame: Baseline to Week 16). 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 4 Jan 2019.