Moderate to Severe Plaque PsoriasisPhase 1NCT02607774
Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis
A Phase 1 study testing Midazolam and AIN457 in people with Moderate to Severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 8 sites in United States.
Trial summary
To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- Midazolam and AIN457
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Dec 2015to 20 Dec 2016
- Phase
- Phase 1
- 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
- Moderate to severe plaque psoriasis as defined at baseline by: PASI score of 12 or greater and IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4) and Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy
- Men or women at least 18 years of age or older at time of screening.
Who cannot join
- Forms of psoriasis other than chronic plaque-type
- Pregnant or nursing (lactating) women,
- History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection.
- Subjects with known history of hypersensitivity to midazolam
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Fair Lawn, New Jersey, 07410
Novartis Investigative Site
Hot Springs, Arkansas, 71913
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Verona, New Jersey, 07044
Novartis Investigative Site
Webster, Texas, 77004
About this study
Official title: An Open-label, Single Sequence Crossover, Study Investigating the Influence of Secukinumab Treatment on the Pharmacokinetics of Midazolam as a CYP3A4 Substrate in Patients With Moderate to Severe Plaque Psoriasis
To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.
Read the detailed description
This will be an open-label, confirmatory study investigating potential disease-drug-drug interaction of secukinumab and midazolam in male and female patients with moderate-to-severe plaque psoriasis. A total of approximately 25 patients are required to obtain at least 20 completers in the study Patients who meet the eligibility criteria at screening, will have a baseline assessment day (within 1 week prior to the start of secukinumab) during which a full midazolam PK profile after a single oral dose of 5 mg will be assessed by collecting blood over the 12 hour postdose period.
On Day 1 (Week 0), Day 8 (Week 1), Day 15 (Week 2), Day 22 (Week 3) and Day 29 (Week 4) patients will receive 300 mg s.c. secukinumab (2 injections of 150 mg s.c.). On Day 8 and on Day 36 (Week 5), patients will receive additional single doses of 5 mg oral midazolam (total of 3 single doses). The midazolam PK profile will be assessed over the 12 hour postdose period.
On those days when midazolam PK profiles are assessed, samples will be collected and analyzed for circulating IL-6, inflammatory panel (collected at screening, baseline and pre-dose Day 1 only), total IL-17A (after following initiation of secukinumab treatment), hsCRP and for 4-beta-hydroxycholesterol (exploratory endogenous phenotyping marker of CYP3A activity).
There will be an extended treatment period during which patients will receive secukinumab 300 mg s.c. at Weeks 8, 12, 16, 20 and 24.
Then there will be a follow-up period of 12 weeks following the last dose administered at Week 24. Visits will be at Weeks 28, 32 and 36.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- Midazolam, AIN457
- Keywords
- Plaque psoriasis, disease-drug-drug-interaction, midazolam, secukinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
midazolam administered to all patients Days -7, 1 and 35.
AIN457Drug
Also called Secukinumab
secukinumab administered at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Secukinumab over 24 weeks Receives: Drug: Midazolam; Drug: AIN457 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum plasma) concentration
Measured: Days -7, 8 and 36
AUC0-12 (area under the plasma concentration-time curve from time zero to time 12 hours )
Measured: Days -7, 8 and 36
AUClast (area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Measured: Days -7, 8 and 36
AUCinf (area under the plasma concentration-time curve from time zero to infinity)
Measured: Days -7, 8 and 36
Secondary outcomes (1)
safety and tolerability (including; Blood pressure,Pulse Rate,AEs/SAEs, Blood chemistry, Hematology, ECGs and physical exam
Measured: Throughout the entire trial; beginning at screening through Day 253 (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start17 Dec 2015
- Primary completion20 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607774
- Sponsor's protocol ID
- CAIN457A2110
- Status last verified
- Mar 2019
- First submitted
- 3 Nov 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Sequence Crossover, Study Investigating the Influence of Secukinumab Treatment on the Pharmacokinetics of Midazolam as a CYP3A4 Substrate in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02607774
- Acronym / sponsor ID
- CAIN457A2110
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- Plaque psoriasis, disease-drug-drug-interaction, midazolam, secukinumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 18 Nov 2015 (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.
To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.
Detailed description
This will be an open-label, confirmatory study investigating potential disease-drug-drug interaction of secukinumab and midazolam in male and female patients with moderate-to-severe plaque psoriasis. A total of approximately 25 patients are required to obtain at least 20 completers in the study Patients who meet the eligibility criteria at screening, will have a baseline assessment day (within 1 week prior to the start of secukinumab) during which a full midazolam PK profile after a single oral dose of 5 mg will be assessed by collecting blood over the 12 hour postdose period.
On Day 1 (Week 0), Day 8 (Week 1), Day 15 (Week 2), Day 22 (Week 3) and Day 29 (Week 4) patients will receive 300 mg s.c. secukinumab (2 injections of 150 mg s.c.). On Day 8 and on Day 36 (Week 5), patients will receive additional single doses of 5 mg oral midazolam (total of 3 single doses). The midazolam PK profile will be assessed over the 12 hour postdose period.
On those days when midazolam PK profiles are assessed, samples will be collected and analyzed for circulating IL-6, inflammatory panel (collected at screening, baseline and pre-dose Day 1 only), total IL-17A (after following initiation of secukinumab treatment), hsCRP and for 4-beta-hydroxycholesterol (exploratory endogenous phenotyping marker of CYP3A activity).
There will be an extended treatment period during which patients will receive secukinumab 300 mg s.c. at Weeks 8, 12, 16, 20 and 24.
Then there will be a follow-up period of 12 weeks following the last dose administered at Week 24. Visits will be at Weeks 28, 32 and 36.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: Midazolam, Drug: AIN457Secukinumab over 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe plaque psoriasis as defined at baseline by: PASI score of 12 or greater and IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4) and Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy
- Men or women at least 18 years of age or older at time of screening.
Key exclusion criteria (4 listed)
- Forms of psoriasis other than chronic plaque-type
- Pregnant or nursing (lactating) women,
- History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection.
- Subjects with known history of hypersensitivity to midazolam
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 |
|---|---|---|
| Midazolammidazolam administered to all patients Days -7, 1 and 35. | Drug | Secukinumab |
| AIN457Also: Secukinumabsecukinumab administered at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 | Drug | Secukinumab |
Primary outcome
Cmax (maximum plasma) concentration
Time frame: Days -7, 8 and 36
AUC0-12 (area under the plasma concentration-time curve from time zero to time 12 hours )
Time frame: Days -7, 8 and 36
AUClast (area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
Time frame: Days -7, 8 and 36
AUCinf (area under the plasma concentration-time curve from time zero to infinity)
Time frame: Days -7, 8 and 36
1 secondary outcome
safety and tolerability (including; Blood pressure,Pulse Rate,AEs/SAEs, Blood chemistry, Hematology, ECGs and physical exam
Time frame: Throughout the entire trial; beginning at screening through Day 253 (end of trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Results for CAIN457A2110 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam and AIN457 in people with Moderate to Severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 8 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 3 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (maximum plasma) concentration (time frame: Days -7, 8 and 36). The study lists 4 primary outcomes in all. 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 11 Dec 2020.