PsoriasisPhase 4INTERCEPTNCT04488185

An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

A Phase 4 study testing Secukinumab 300 mg in people with Psoriasis, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Secukinumab 300 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 2 Nov 2020to 24 Mar 2021
Phase: Phase 4
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

Clinical diagnosis of chronic plaque-type psoriasis confirmed through physical examination by a dermatologist, with at least six months of clinical history prior to the baseline visit
Moderate to severe plaque psoriasis at baseline as defined as:
≥ 10 % Body Surface Area (BSA) involvement, or
≥ 3% to <10% Body Surface Area with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent
Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies
Presence of sonographic enthesitis at screening, in at least one enthesis, defined by the presence of at least abnormal thickening and hypoechogenicity of the tendon insertion, with or without presence of Doppler signal (Grade 0-3), or by the presence of grade ≥ 2 Doppler signal, independent of gray scale abnormalities

Who cannot join

Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints
Exposure to any IL-17 or IL-23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within twelve months prior to screening, or exposure to any inhibitors of TNF-ɑ and IL12/23 within six months prior to screening
Previous exposure to non-biologic systemic therapy for psoriasis, including methotrexate, PDE-4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half-lives (whichever is longer) prior to screening
A degree of obesity that impedes proper ultrasound examination of entheses and joints
Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g., erythrodermic, generalized or localized pustular psoriasis, or new onset guttate psoriasis)
Other protocol-defined inclusion/exclusion criteria may apply

About this study

Official title: An Exploratory, Randomized, Double-blind, Parallel-group, Multicenter Study to Compare Secukinumab 300 mg With Placebo After 16 Weeks of Treatment in Adults With Moderate to Severe Plaque Psoriasis and Subclinical Enthesitis Measured by Musculoskeletal Ultrasound

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of subclinical enthesitis in psoriasis patients. This study will be the first randomized trial of a biologic therapy versus placebo in participants with plaque psoriasis and subclinical psoriatic arthritis, using musculoskeletal ultrasound.

Read the detailed description

The primary objective of this study is to estimate the difference in effect between secukinumab 300 mg s.c. and placebo, based on change from baseline to Week 16 in the OMERACT ultrasound enthesitis score.

Conditions: Psoriasis
Being tested: Secukinumab 300 mg, Placebo
Keywords: Psoriasis, Subclinical enthesitis, secukinumab, subclinical psoriatic arthritis, Plaque psoriasis, AIN457
Medical subject headings: Psoriasis

What participants receive

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

Secukinumab 300 mgBiological
Also called AIN457
Secukinumab 300 mg administered s.c. (2 single-use prefilled syringes of 150 mg/mL), on Days 1, 8, 15, 22, 29, 57, 85.
PlaceboOther
Placebo administered s.c. (2 single-use prefilled 1 mL syringes) on Days 1, 8, 15, 22, 29, 57, 85.

Study groups in NCT04488185
Study group	Role	What they receive
Secukinumab 300mg	Experimental	Randomized in a 2:1 ratio to secukinumab or placebo Receives: Biological: Secukinumab 300 mg
Placebo	Placebo comparator	Randomized in a 2:1 ratio to secukinumab or placebo Receives: Other: Placebo

What is being measured

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

Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score
Twelve (12) entheses (bilateral AT, LE, PP, DP, PA, QT) will be scored in terms of inflammatory and morphological components according to the OMERACT enthesitis composite semi-quantitative scale (0 to 3). The lowest OMERACT score a participant can have at baseline is 2 (based on Inclusion Criterion number 6, which requires at least 2 points in the B-mode or the Doppler mode in at least one enthesis). The highest OMERACT score expected at baseline will be 72, assuming that each of the 12 entheses assessed shows a maximum of 3 points in the gray scale score, and a maximum of 3 points in the Doppler score. The largest change expected from baseline to Week 16 is -60 points (improvement). This assumes that the presence of structural changes (calcifications, enthesophytes and erosions) may add a maximum of 12 points to the score, and it may not be modifiable with study treatment during the study period.
Measured: Baseline and Week 16

Secondary outcomes (11)

Change from Baseline in the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) ultrasound enthesitis score
Sixteen (16) entheses (bilateral AT, LE, PP, DP, PA, QT, SS, TT) will be scored in terms of inflammatory components according with the GRAPPA ultrasound enthesitis score. The lowest GRAPPA score a participant may have at baseline is 2 (based on Inclusion Criterion number 6, which requires at least 2 points in the B-mode or the Doppler mode in at least 1 enthesis). The highest GRAPPA score expected at baseline is 248, assuming the maximum score that could be assigned to each enthesis. The largest change expected from baseline to Week 16 is -136 points (improvement). This value assumes that the presence of structural changes (calcifications, enthesophytes, and erosions) may add a maximum of 136 points to the score, and it may not be modifiable with study treatment during the study period.
Measured: Baseline and Week 16
Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis
Joints examined by the PsASon13 unilateral ultrasound composite score: Small finger joints: MCP2, MCP5, H-PIP1, H-PIP2, H-PIP3; Distal interphalangeal finger joints: H-DIP3; Small joints of feet: MTP1, MTP5, F-PIP1; Distal interphalangeal joints of feet: F-DIP2, F-DIP3; Large joints: wrist and knee. Lowest score a participant may have at baseline is 0. Highest score a participant may have at baseline is 184 (5 small finger joints, each ranging from 0 to 18; 1 distal interphalangeal finger joint, each ranging from 0 to 16; 3 small joints of feet, each ranging from 0 to 12; 2 distal interphalangeal joints of feet, each ranging from 0 to 12; 1 wrist ranging from 0 to 12; and 1 knee ranging from 0 to 6). Largest change expected from baseline to Week 16 is -118 points (improvement). This assumes that the presence of structural changes (erosions and osteophytes) may add a maximum of 66 points to the score and it may not be modifiable with study treatment during the study period.
Measured: Baseline and Week 16
Number of participants who achieve complete resolution of enthesitis based on OMERACT criteria (yes, no)
Proportion of participants experiencing complete resolution of their enthesitis based on Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) score
Measured: Baseline and Week 16
Number of participants who achieve Psoriasis Area and Severity Index 90 (PASI 90) (yes, no)
Psoriasis Area Severity Index 90
Scores range from 0 to 72. A score of more than 10 generally translates to "moderate-to-severe". Usually, the higher your PASI score, the lower the quality of life. A PASI 90 is at least a 90% improvement (reduction) in PASI score.
Measured: Baseline and Week 16
Number of participants who achieve Psoriasis Area and Severity Index 100 (PASI 100) (yes, no)
Psoriasis Area Severity Index 100
Scores range from 0 to 72. A score of more than 10 generally translates to "moderate-to-severe". Usually, the higher your PASI score, the lower the quality of life. A PASI 100 is a complete clearing of psoriasis (PASI score = 0).
Measured: Baseline and Week 16
Number of participants who achieve Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 (yes, no)
The IGA mod 2011 scale is a visual assessment that consists of a score ranging from 0 (clear) to 4 (severe). Skin rated a 4 is bright red in color with marked plaque elevation and is dominated by thick, non-tenacious scale. For a treatment to be considered successful, the affected area must receive a score of 0 or 1 and experience a two-point improvement from Baseline.
Measured: Baseline and Week 16
Change from Baseline in Body Surface Area (BSA)
The total percentage of body surface area affected by psoriasis
Measured: Baseline and Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) score
A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.
Measured: Baseline and Week 16
Number of participants who achieve Dermatology Life Quality Index (DLQI) score of 0 or 1 (yes, no)
A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.
Measured: Baseline and Week 16
Change from Baseline in HAQ-DI score
Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Measured: Baseline and Week 16
Number of participants who achieve HAQ-DI change from baseline ≤ -0.35 (yes, no)
Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Measured: Baseline and Week 16

Timeline

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

2 Nov 202024 Mar 2021

First posted27 Jul 2020
Study start2 Nov 2020
Primary completion24 Mar 2021
Study completion24 Mar 2021

Why it stopped: low recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04488185
Sponsor's protocol ID: CAIN457AUS26
Acronym: INTERCEPT
Status last verified: Mar 2023
First submitted: 26 Jun 2020
Last updated: 31 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

Acquitter M, Misery L, Saraux A, Bressollette L, Jousse-Joulin S. Detection of subclinical ultrasound enthesopathy and nail disease in patients at risk of psoriatic arthritis. Joint Bone Spine. 2017 Dec;84(6):703-707. doi: 10.1016/j.jbspin.2016.10.005. Epub 2016 Dec 5.
PubMed 27932277
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013 Oct;149(10):1180-5. doi: 10.1001/jamadermatol.2013.5264.
PubMed 23945732
Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.
PubMed 18795920
Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9.
PubMed 17216680
Chen M, Kianifard F. A nonparametric procedure associated with a clinically meaningful efficacy measure. Biostatistics. 2000 Sep;1(3):293-8. doi: 10.1093/biostatistics/1.3.293.
PubMed 12933510
Doherty SD, Van Voorhees A, Lebwohl MG, Korman NJ, Young MS, Hsu S, National Psoriasis Foundation. National Psoriasis Foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents. J Am Acad Dermatol. 2008 Aug;59(2):209-17. doi: 10.1016/j.jaad.2008.03.023. Epub 2008 May 15.
PubMed 18485527
El Miedany Y, El Gaafary M, Youssef S, Ahmed I, Nasr A. Tailored approach to early psoriatic arthritis patients: clinical and ultrasonographic predictors for structural joint damage. Clin Rheumatol. 2015 Feb;34(2):307-13. doi: 10.1007/s10067-014-2630-2. Epub 2014 May 3.
PubMed 24794490
Elnady B, El Shaarawy NK, Dawoud NM, Elkhouly T, Desouky DE, ElShafey EN, El Husseiny MS, Rasker JJ. Subclinical synovitis and enthesitis in psoriasis patients and controls by ultrasonography in Saudi Arabia; incidence of psoriatic arthritis during two years. Clin Rheumatol. 2019 Jun;38(6):1627-1635. doi: 10.1007/s10067-019-04445-0. Epub 2019 Feb 12.
PubMed 30756253
Faustini F, Simon D, Oliveira I, Kleyer A, Haschka J, Englbrecht M, Cavalcante AR, Kraus S, Tabosa TP, Figueiredo C, Hueber AJ, Kocijan R, Cavallaro A, Schett G, Sticherling M, Rech J. Subclinical joint inflammation in patients with psoriasis without concomitant psoriatic arthritis: a cross-sectional and longitudinal analysis. Ann Rheum Dis. 2016 Dec;75(12):2068-2074. doi: 10.1136/annrheumdis-2015-208821. Epub 2016 Feb 25.
PubMed 26916344
Feldman SR, Zhao Y, Shi L, Tran MH. Economic and Comorbidity Burden Among Patients with Moderate-to-Severe Psoriasis. J Manag Care Spec Pharm. 2015 Oct;21(10):874-88. doi: 10.18553/jmcp.2015.21.10.874.
PubMed 26402388
Ficjan A, Husic R, Gretler J, Lackner A, Graninger WB, Gutierrez M, Duftner C, Hermann J, Dejaco C. Ultrasound composite scores for the assessment of inflammatory and structural pathologies in Psoriatic Arthritis (PsASon-Score). Arthritis Res Ther. 2014 Oct 31;16(5):476. doi: 10.1186/s13075-014-0476-2.
PubMed 25361855
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
PubMed 357213
Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
PubMed 15708927
Gottlieb AB, Griffiths CE, Ho VC, Lahfa M, Mrowietz U, Murrell DF, Ortonne JP, Todd G, Cherill R, Marks I, Emady-Azar S, Paul CF; Multi-Centre Investigator Group. Oral pimecrolimus in the treatment of moderate to severe chronic plaque-type psoriasis: a double-blind, multicentre, randomized, dose-finding trial. Br J Dermatol. 2005 Jun;152(6):1219-27. doi: 10.1111/j.1365-2133.2005.06661.x.
PubMed 15948985

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?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory, Randomized, Double-blind, Parallel-group, Multicenter Study to Compare Secukinumab 300 mg With Placebo After 16 Weeks of Treatment in Adults With Moderate to Severe Plaque Psoriasis and Subclinical Enthesitis Measured by Musculoskeletal Ultrasound
ClinicalTrials.gov ID: NCT04488185
Acronym / sponsor ID: INTERCEPT / CAIN457AUS26
Conditions: Psoriasis
Keywords: Psoriasis, Subclinical enthesitis, secukinumab, subclinical psoriatic arthritis, Plaque psoriasis, AIN457
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: low recruitment
Enrolment: 0 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 2 Nov 2020 (actual)
Primary completion: 24 Mar 2021 (actual)
Study completion: 24 Mar 2021 (actual)
First posted: 27 Jul 2020 (actual)
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.

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 300mg	Experimental	Biological: Secukinumab 300 mgRandomized in a 2:1 ratio to secukinumab or placebo
Placebo	Placebo comparator	Other: PlaceboRandomized in a 2:1 ratio to secukinumab or placebo

Who may qualify

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

Key inclusion criteria (6 listed)

Clinical diagnosis of chronic plaque-type psoriasis confirmed through physical examination by a dermatologist, with at least six months of clinical history prior to the baseline visit
Moderate to severe plaque psoriasis at baseline as defined as:
≥ 10 % Body Surface Area (BSA) involvement, or
≥ 3% to <10% Body Surface Area with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent
Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies

Key exclusion criteria (6 listed)

Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints
Exposure to any IL-17 or IL-23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within twelve months prior to screening, or exposure to any inhibitors of TNF-ɑ and IL12/23 within six months prior to screening
Previous exposure to non-biologic systemic therapy for psoriasis, including methotrexate, PDE-4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half-lives (whichever is longer) prior to screening
A degree of obesity that impedes proper ultrasound examination of entheses and joints
Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g., erythrodermic, generalized or localized pustular psoriasis, or new onset guttate psoriasis)

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
Secukinumab 300 mgAlso: AIN457Secukinumab 300 mg administered s.c. (2 single-use prefilled syringes of 150 mg/mL), on Days 1, 8, 15, 22, 29, 57, 85.	Biological	Secukinumab 300mg
PlaceboPlacebo administered s.c. (2 single-use prefilled 1 mL syringes) on Days 1, 8, 15, 22, 29, 57, 85.	Other	Placebo

Primary outcome

Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score
Time frame: Baseline and Week 16
Twelve (12) entheses (bilateral AT, LE, PP, DP, PA, QT) will be scored in terms of inflammatory and morphological components according to the OMERACT enthesitis composite semi-quantitative scale (0 to 3). The lowest OMERACT score a participant can have at baseline is 2 (based on Inclusion Criterion number 6, which requires at least 2 points in the B-mode or the Doppler mode in at least one enthesis). The highest OMERACT score expected at baseline will be 72, assuming that each of the 12 entheses assessed shows a maximum of 3 points in the gray scale score, and a maximum of 3 points in the Doppler score. The largest change expected from baseline to Week 16 is -60 points (improvement). This assumes that the presence of structural changes (calcifications, enthesophytes and erosions) may add a maximum of 12 points to the score, and it may not be modifiable with study treatment during the study period.

11 secondary outcomes

Change from Baseline in the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) ultrasound enthesitis score
Time frame: Baseline and Week 16
Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis
Time frame: Baseline and Week 16
Number of participants who achieve complete resolution of enthesitis based on OMERACT criteria (yes, no)
Time frame: Baseline and Week 16
Number of participants who achieve Psoriasis Area and Severity Index 90 (PASI 90) (yes, no)
Time frame: Baseline and Week 16
Number of participants who achieve Psoriasis Area and Severity Index 100 (PASI 100) (yes, no)
Time frame: Baseline and Week 16
Number of participants who achieve Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 (yes, no)
Time frame: Baseline and Week 16
Change from Baseline in Body Surface Area (BSA)
Time frame: Baseline and Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) score
Time frame: Baseline and Week 16
Number of participants who achieve Dermatology Life Quality Index (DLQI) score of 0 or 1 (yes, no)
Time frame: Baseline and Week 16
Change from Baseline in HAQ-DI score
Time frame: Baseline and Week 16
Number of participants who achieve HAQ-DI change from baseline ≤ -0.35 (yes, no)
Time frame: Baseline and Week 16

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 31 Mar 2023.
Background: PubMed 27932277Acquitter M, Misery L, Saraux A, Bressollette L, Jousse-Joulin S. Detection of subclinical ultrasound enthesopathy and nail disease in patients at risk of psoriatic arthritis. Joint Bone Spine. 2017 Dec;84(6):703-707. doi: 10.1016/j.jbspin.2016.10.005. Epub 2016 Dec 5.
Background: PubMed 23945732Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013 Oct;149(10):1180-5. doi: 10.1001/jamadermatol.2013.5264.
Background: PubMed 18795920Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.
Background: PubMed 17216680Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9.
Background: PubMed 12933510Chen M, Kianifard F. A nonparametric procedure associated with a clinically meaningful efficacy measure. Biostatistics. 2000 Sep;1(3):293-8. doi: 10.1093/biostatistics/1.3.293.
Background: PubMed 18485527Doherty SD, Van Voorhees A, Lebwohl MG, Korman NJ, Young MS, Hsu S, National Psoriasis Foundation. National Psoriasis Foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents. J Am Acad Dermatol. 2008 Aug;59(2):209-17. doi: 10.1016/j.jaad.2008.03.023. Epub 2008 May 15.
Background: PubMed 24794490El Miedany Y, El Gaafary M, Youssef S, Ahmed I, Nasr A. Tailored approach to early psoriatic arthritis patients: clinical and ultrasonographic predictors for structural joint damage. Clin Rheumatol. 2015 Feb;34(2):307-13. doi: 10.1007/s10067-014-2630-2. Epub 2014 May 3.
Background: PubMed 30756253Elnady B, El Shaarawy NK, Dawoud NM, Elkhouly T, Desouky DE, ElShafey EN, El Husseiny MS, Rasker JJ. Subclinical synovitis and enthesitis in psoriasis patients and controls by ultrasonography in Saudi Arabia; incidence of psoriatic arthritis during two years. Clin Rheumatol. 2019 Jun;38(6):1627-1635. doi: 10.1007/s10067-019-04445-0. Epub 2019 Feb 12.
Background: PubMed 26916344Faustini F, Simon D, Oliveira I, Kleyer A, Haschka J, Englbrecht M, Cavalcante AR, Kraus S, Tabosa TP, Figueiredo C, Hueber AJ, Kocijan R, Cavallaro A, Schett G, Sticherling M, Rech J. Subclinical joint inflammation in patients with psoriasis without concomitant psoriatic arthritis: a cross-sectional and longitudinal analysis. Ann Rheum Dis. 2016 Dec;75(12):2068-2074. doi: 10.1136/annrheumdis-2015-208821. Epub 2016 Feb 25.
Background: PubMed 26402388Feldman SR, Zhao Y, Shi L, Tran MH. Economic and Comorbidity Burden Among Patients with Moderate-to-Severe Psoriasis. J Manag Care Spec Pharm. 2015 Oct;21(10):874-88. doi: 10.18553/jmcp.2015.21.10.874.
Background: PubMed 25361855Ficjan A, Husic R, Gretler J, Lackner A, Graninger WB, Gutierrez M, Duftner C, Hermann J, Dejaco C. Ultrasound composite scores for the assessment of inflammatory and structural pathologies in Psoriatic Arthritis (PsASon-Score). Arthritis Res Ther. 2014 Oct 31;16(5):476. doi: 10.1186/s13075-014-0476-2.
Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

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Plaque Psoriasis
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A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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 4 study testing Secukinumab 300 mg 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 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: withdrawn, as of the sponsor's last update on 31 Mar 2023. 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 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?

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?

Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score (time frame: Baseline and Week 16). 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 NCT04488185, which also lists 28 linked publications.

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 31 Mar 2023.