Plaque PsoriasisPhase 4ObePso-SNCT03055494

Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

A Phase 4 study testing Secukinumab in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Plaque Psoriasis
What is being tested?: Secukinumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 15 sitesUnited States
Study dates: 18 Apr 2017to 26 Feb 2019
Phase: Phase 4
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

Written informed consent must be obtained before any assessment is performed
Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
Moderate to severe plaque psoriasis as defined at baseline by:
≥10% Body Surface Area (BSA) involvement and
PASI total score of ≥12 and
IGA mod 2011 score of ≥3 (based on a scale of 0-4)

Who cannot join

Forms of diagnosed psoriasis other than chronic plaque psoriasis
Medication-induced or medication exacerbated psoriasis
Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
Ongoing use of prohibited treatments
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Buffalo, New York, 14203
Novartis Investigative Site
East Windsor, New Jersey, 08520
Novartis Investigative Site
Hot Springs, Arkansas, 71913
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Murray, Utah, 84107
Novartis Investigative Site
New York, New York, 10025 1737
Novartis Investigative Site
New York, New York, 10065
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213-3403
Novartis Investigative Site
Portland, Oregon, 97223
Novartis Investigative Site
Santa Ana, California, 92701
Novartis Investigative Site
Webster, Texas, 77004
Novartis Investigative Site
West Orange, New Jersey, 07052

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore Changes in Subcutaneous Adipose Tissue and Modulation of Skin Inflammation After 12 Weeks of Treatment With Secukinumab, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis

This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.

Read the detailed description

This was a randomized, double-blind, placebo-controlled, multicenter design. Patients with moderate to severe plaque psoriasis received secukinumab 300 mg or placebo, with randomization stratified by body weight (< 90 kg, ≥ 90 kg). There were 5 periods to the study: Screening (1 to 4 weeks), Double-blind Treatment Period (12 weeks), Double-blind Induction Period (4 weeks), Open-label Treatment Period (36 weeks), and Follow-up Period (1 week).

During the Double-blind Treatment Period, all patients attended study visits at Baseline, Weeks 1, 2, 3, 4, 8, and 12, and all doses of study treatment were self-administered at the study site. Patients underwent lesional (LS) and non-lesional (NL) skin biopsies at Baseline and Week 12. Assessments for the primary efficacy variable were performed at Week 12 before patients received their Week 12 dose. During the Double-blind Induction Period, patients randomized to placebo were switched to secukinumab 300 mg for the remainder of the study.

K16 and skin histology/biomarkers were assessed from skin biopsies. The Psoriasis Assessment and Severity Index (PASI) and the Investigator's Global Assessment modified 2011 scale (IGA mod 2011) were performed at specified study visits. Safety was monitored by vital signs, weight, waist circumference, body mass index (BMI), and clinical laboratory tests (serum chemistry, hematology, highsensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), homeostatic assessment of insulin resistance (HOMA-IR), viral serology, serum and urine pregnancy).

Conditions: Plaque Psoriasis
Being tested: Secukinumab, Placebo
Keywords: scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibod, psoriasis, AIN457A
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SecukinumabBiological
Also called AIN457
Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48
PlaceboBiological
Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48

Study groups in NCT03055494
Study group	Role	What they receive
Secukinumab	Experimental	Eligible patients received secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48 Receives: Biological: Secukinumab
Placebo	Placebo comparator	Eligible patients received placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients were switched to treatment with secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48 Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12
Response in skin histology/K16 expression to treatment (answered no)
Measured: 12 weeks
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12
Psoriasis Area and Severity Index 90
Measured: 12 weeks

Secondary outcomes (10)

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52
Response in skin histology/K16 expression to treatment (answered no)
Measured: 52 weeks
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52
Psoriasis Area and Severity Index 90
Measured: 52 weeks
Change in Systolic Blood Pressure From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Measured: baseline, Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Measured: baseline, Week 12
Change in Body Weight From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Measured: baseline, Week 12
Change in Glucose Level From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Measured: baseline, Week 12
Change in Insulin Level From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Measured: baseline, Week 12
Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Measured: baseline, Week 12
Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12
Vital signs: summary statistics for change from baseline to Week 12
Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Measured: baseline, Week 12
Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12
Vital signs: summary statistics for change from baseline to week 12
For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes.
Measured: baseline, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201726 Feb 2019

First posted16 Feb 2017
Study start18 Apr 2017
Primary completion25 Apr 2018
Study completion26 Feb 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03055494
Sponsor's protocol ID: CAIN457AUS07
Acronym: ObePso-S
Status last verified: Mar 2023
First submitted: 14 Feb 2017
Last updated: 10 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

Publications

Shishido-Takahashi N, Garcet S, Cueto I, Hur HB, Muscianisi E, Steadman J, Blauvelt A, Krueger JG. Cutaneous adipose tissue carries a strong inflammatory signature in patients with psoriasis. JCI Insight. 2026 Mar 3;11(7):e194171. doi: 10.1172/jci.insight.194171. eCollection 2026 Apr 8.
PubMed 41774505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore Changes in Subcutaneous Adipose Tissue and Modulation of Skin Inflammation After 12 Weeks of Treatment With Secukinumab, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT03055494
Acronym / sponsor ID: ObePso-S / CAIN457AUS07
Conditions: Plaque Psoriasis
Keywords: scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibod, psoriasis, AIN457A
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 18 Apr 2017 (actual)
Primary completion: 25 Apr 2018 (actual)
Study completion: 26 Feb 2019 (actual)
First posted: 16 Feb 2017 (actual)
Results: Posted 10 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Secukinumab	Experimental	Biological: SecukinumabEligible patients received secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48
Placebo	Placebo comparator	Biological: PlaceboEligible patients received placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients were switched to treatment with secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Written informed consent must be obtained before any assessment is performed
Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
Moderate to severe plaque psoriasis as defined at baseline by:

Key exclusion criteria (6 listed)

Forms of diagnosed psoriasis other than chronic plaque psoriasis
Medication-induced or medication exacerbated psoriasis
Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
Ongoing use of prohibited treatments
Pregnant or nursing (lactating) women

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
SecukinumabAlso: AIN457Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48	Biological	Secukinumab
PlaceboPlacebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48	Biological	Placebo

Primary outcome

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12
Time frame: 12 weeks
Response in skin histology/K16 expression to treatment (answered no)
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12
Time frame: 12 weeks
Psoriasis Area and Severity Index 90

10 secondary outcomes

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52
Time frame: 52 weeks
Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52
Time frame: 52 weeks
Change in Systolic Blood Pressure From Baseline to Week 12
Time frame: baseline, Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12
Time frame: baseline, Week 12
Change in Body Weight From Baseline to Week 12
Time frame: baseline, Week 12
Change in Glucose Level From Baseline to Week 12
Time frame: baseline, Week 12
Change in Insulin Level From Baseline to Week 12
Time frame: baseline, Week 12
Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12
Time frame: baseline, Week 12
Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12
Time frame: baseline, Week 12
Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12
Time frame: baseline, week 12

Results and safety

Results posted to the registry on 10 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Secukinumab 300 mg	54	44
Placebo/Secukinumab 300 mg	28	27

Primary outcome: Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Secukinumab 300 mg n = 54	Placebo n = 28
Value	43	1

Secukinumab 300 mg vs Placebo: difference in percentages: 76.1 (95% CI 63.3 to 88.8), 95% confidence interval

Population analysed: Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.

Primary outcome: Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Secukinumab 300 mg n = 54	Placebo n = 28
Value	29	0

Secukinumab 300 mg vs Placebo: difference in percentages: 55.8 (95% CI 42.3 to 69.3), 95% confidence interval

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Secukinumab 300 mg	1 of 54 (1.9%)	39 of 54 (72.2%)	0 of 54
Placebo/Secukinumab 300 mg	1 of 28 (3.6%)	25 of 28 (89.3%)	0 of 28

Limitations and caveats (from the sponsor): Change in Body Mass Index (BMI) was not measured

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41774505Shishido-Takahashi N, Garcet S, Cueto I, Hur HB, Muscianisi E, Steadman J, Blauvelt A, Krueger JG. Cutaneous adipose tissue carries a strong inflammatory signature in patients with psoriasis. JCI Insight. 2026 Mar 3;11(7):e194171. doi: 10.1172/jci.insight.194171. eCollection 2026 Apr 8.
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 Plaque Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

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.

Study Lead Novartis Pharmaceuticals study director

Novartis

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 15 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 6 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Mar 2020). 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?

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03055494, which also lists 1 linked publication.

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 10 Mar 2023.