Chronic Plaque-type PsoriasisPhase 2NCT01071252
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
A Phase 2 study testing AIN457 in people with Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 19 sites in 6 countries.
Trial summary
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque-type Psoriasis
- What is being tested?
- AIN457
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 19 sitesin 6 countries
- Study dates
- Mar 2010to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- At randomization, moderate to severe psoriasis as defined by:
- PASI score of 12 or greater and,
- IGA score of 3 or greater and,
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
Who cannot join
- Forms of psoriasis other than chronic plaque-type
- Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
- Previous exposure to AIN457
- Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- Known immunosuppression (e.g., AIDS) at screening and / or randomization
- History or evidence of active tuberculosis at screening
Show all 14Show fewer
- Active systemic infections (other than common cold)
- History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
- Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
- Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
- Inability or unwillingness to undergo repeated venipuntures
- History or evidence of drug or alcohol abuse
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
United States5 sites
Novartis Investigative Site
Lake Oswego, Oregon, 97035
Novartis Investigative Site
Louisville, Kentucky, 40217
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Rochester, New York, 14623
Novartis Investigative Site
San Diego, California, 92123
Japan4 sites
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Saitama, Saitama, 330-0854
Novartis Investigative Site
Sapporo, Hokkaido, 060-0063
Canada3 sites
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1Z2
Novartis Investigative Site
North Bay, Ontario, P1B 3Z7
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Estonia3 sites
Novartis Investigative Site
Tallinn, Estonia, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 51014
Latvia3 sites
Novartis Investigative Site
Riga, 1012
Novartis Investigative Site
Riga, LV-1001
Novartis Investigative Site
Riga
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
- Conditions
- Chronic Plaque-type Psoriasis
- Being tested
- AIN457, Placebo
- Keywords
- Moderate to severe chronic plaque-type psoriasis, AIN457, dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AIN457 1x25mg | Experimental | Not described Receives: Drug: AIN457 |
| AIN457 3x25mg | Experimental | Not described Receives: Drug: AIN457 |
| AIN457 3x75mg | Experimental | Not described Receives: Drug: AIN457 |
| AIN457 3x150mg | Experimental | Not described Receives: Drug: AIN457 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Measured: week 13
Secondary outcomes (3)
Percentage of Participants With Investigator's Global Assessment (IGA) Response
IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
Measured: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Measured: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
To Assess the Time to Relapse
Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
Measured: 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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-type 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 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
- NCT01071252
- Sponsor's protocol ID
- CAIN457A2220
- Other IDs
- 2009-016807-42, 2009
- Status last verified
- Feb 2015
- First submitted
- 18 Feb 2010
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT01071252
- Acronym / sponsor ID
- CAIN457A2220
- Conditions
- Chronic Plaque-type Psoriasis
- Keywords
- Moderate to severe chronic plaque-type psoriasis, AIN457, dermatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 16 Feb 2015
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 the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AIN457 1x25mg | Experimental | Drug: AIN457 |
| AIN457 3x25mg | Experimental | Drug: AIN457 |
| AIN457 3x75mg | Experimental | Drug: AIN457 |
| AIN457 3x150mg | Experimental | Drug: AIN457 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- PASI score of 12 or greater and,
- IGA score of 3 or greater and,
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
Key exclusion criteria (14 listed)
- Forms of psoriasis other than chronic plaque-type
- Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
- Previous exposure to AIN457
- Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- Known immunosuppression (e.g., AIDS) at screening and / or randomization
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 | Drug | AIN457 1x25mg, AIN457 3x150mg, AIN457 3x25mg, AIN457 3x75mg |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
Time frame: week 13
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
3 secondary outcomes
Percentage of Participants With Investigator's Global Assessment (IGA) Response
Time frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Time frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
To Assess the Time to Relapse
Time frame: 37 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study:Link provided by the sponsor.
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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
19 sites in 6 countries: 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-type Psoriasis, run by Novartis Pharmaceuticals at 19 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 5 inclusion and 14 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Japan, Canada, Estonia, Latvia 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 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 16 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?
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 (time frame: week 13). 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 16 Feb 2015.