Chronic Plaque PsoriasisPhase 2NCT00770965
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
A Phase 2 study testing AIN457 in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- AIN457
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Sep 2008to 17 Sep 2009
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
- Coverage of the body surface area (BSA) of 10% or more with plaques
- A score of 3 or more on the IGA (Investigator Global Assessment) scale
- A PASI score of at least 12 at baseline;
Who cannot join
- Have forms of psoriasis other than the required "plaque psoriasis"
- Women of childbearing potential
- Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
- Previous treatment with this investigational drug
- Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities
- Other protocol-defined inclusion/exclusion criteria may have applied.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Novartis Investigative Site
Duncansville, Pennsylvania, 16634
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Louisville, Kentucky, 40217
Novartis Investigative Site
Nashville, Tennessee, 37215
Novartis Investigative Site
Santa Monica, California, 90404
About this study
Official title: Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- AIN457, Placebo
- Keywords
- Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
- Medical subject headings
- Skin Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| AIN457 0.3 mg/kg | Experimental | Participants received AIN457 0.3 mg/kg IV on Day 1. Receives: Biological: AIN457 |
| AIN457 1.0 mg/kg | Experimental | Participants received AIN457 1.0 mg/kg IV on Day 1. Receives: Biological: AIN457 |
| AIN457 3.0 mg/kg | Experimental | Participants received AIN457 3.0 mg/kg IV on Day 1. Receives: Biological: AIN457 |
| Placebo | Placebo comparator | Participants received placebo to AIN457A IV on day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Measured: baseline, week 4
Secondary outcomes (2)
Change From Baseline in PASI
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Measured: baseline, weeks 12, 14, 16, 20, 24, 28 and 32
Investigator Global Assessment (IGA) Scores
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Measured: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study start10 Sep 2008
- Primary completion17 Sep 2009
- Study completion17 Sep 2009
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 Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Principal investigator, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770965
- Sponsor's protocol ID
- CAIN457A2204
- Status last verified
- Feb 2018
- First submitted
- 9 Oct 2008
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT00770965
- Acronym / sponsor ID
- CAIN457A2204
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2008 (actual)
- Primary completion
- 17 Sep 2009 (actual)
- Study completion
- 17 Sep 2009 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 18 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AIN457 0.3 mg/kg | Experimental | Biological: AIN457Participants received AIN457 0.3 mg/kg IV on Day 1. |
| AIN457 1.0 mg/kg | Experimental | Biological: AIN457Participants received AIN457 1.0 mg/kg IV on Day 1. |
| AIN457 3.0 mg/kg | Experimental | Biological: AIN457Participants received AIN457 3.0 mg/kg IV on Day 1. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants received placebo to AIN457A IV on day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
Key exclusion criteria (6 listed)
- Have forms of psoriasis other than the required "plaque psoriasis"
- Women of childbearing potential
- Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
- Previous treatment with this investigational drug
- Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities
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 |
|---|---|---|
| AIN457 | Biological | AIN457 0.3 mg/kg, AIN457 1.0 mg/kg, AIN457 3.0 mg/kg |
| Placebo | Biological | Placebo |
Primary outcome
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Time frame: baseline, week 4
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
2 secondary outcomes
Change From Baseline in PASI
Time frame: baseline, weeks 12, 14, 16, 20, 24, 28 and 32
Investigator Global Assessment (IGA) Scores
Time frame: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Novartis Pharmaceuticals principal investigator
Novartis Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIN457 in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 5 sites in United States.
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 4 inclusion and 6 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Feb 2015). 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?
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores (time frame: baseline, week 4). 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 12 Mar 2018.