PsoriasisPhase 3NCT01900782
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
A Phase 3 study testing Intervention A and Intervention B in people with Psoriasis, run by Novartis Pharmaceuticals.
Trial summary
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type 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?
- Intervention A and Intervention B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Chronic plaque-type psoriasis, moderate to severe
- Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy
Who cannot join
- Forms of psoriasis other than chronic plaque-type
- Ongoing use of treatments not allowed for psoriasis
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.
- Conditions
- Psoriasis
- Being tested
- Intervention A, Intervention B, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ABiological
Prefilled syringe.
Intervention BBiological
Prefilled syringe.
PlaceboBiological
Prefilled syringe to match experimental drug and active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Dosing Regimen 1 | Experimental | Subcutaneous injection Receives: Biological: Intervention A |
| Active Comparator | Active comparator | Subcutaneous injection Receives: Biological: Intervention B |
| Placebo | Placebo comparator | Subcutaneous injection Receives: Biological: Placebo |
| Dosing Regimen 2 | Experimental | Subcutaneous injection Receives: Biological: Intervention A |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Measured: Week 12
Secondary outcomes (3)
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Measured: Week 52
Vital signs, laboratory values, electrocardiograms (ECG), adverse events
Measured: Week 12 and 52
Patient reported outcome questionnaires
Measured: Week 12 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01900782
- Sponsor's protocol ID
- CAIN457A2314
- Other IDs
- 2013-000463-83
- Status last verified
- Aug 2013
- First submitted
- 12 Jul 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.
- ClinicalTrials.gov ID
- NCT01900782
- Acronym / sponsor ID
- CAIN457A2314
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dosing Regimen 1 | Experimental | Biological: Intervention ASubcutaneous injection |
| Active Comparator | Active comparator | Biological: Intervention BSubcutaneous injection |
| Placebo | Placebo comparator | Biological: PlaceboSubcutaneous injection |
| Dosing Regimen 2 | Experimental | Biological: Intervention ASubcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic plaque-type psoriasis, moderate to severe
- Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy
Key exclusion criteria (3 listed)
- Forms of psoriasis other than chronic plaque-type
- Ongoing use of treatments not allowed for psoriasis
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Intervention APrefilled syringe. | Biological | Dosing Regimen 1, Dosing Regimen 2 |
| Intervention BPrefilled syringe. | Biological | Active Comparator |
| PlaceboPrefilled syringe to match experimental drug and active comparator. | Biological | Placebo |
Primary outcome
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Time frame: Week 12
3 secondary outcomes
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Time frame: Week 52
Vital signs, laboratory values, electrocardiograms (ECG), adverse events
Time frame: Week 12 and 52
Patient reported outcome questionnaires
Time frame: Week 12 and 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention A and Intervention B in people with Psoriasis, run by Novartis Pharmaceuticals.
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 3 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: withdrawn, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 (psoriasis area and severity index) and IGA (investigator's global assessment) (time frame: Week 12). 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 Aug 2013.