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Chronic Plaque Type PsoriasisPhase 3NCT02074982

Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

A Phase 3 study testing AIN457 300 mg and ustekinumab 45/90 mg in people with Chronic Plaque Type Psoriasis, run by Novartis Pharmaceuticals at 137 sites in 24 countries.

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 assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis 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 300 mg and ustekinumab 45/90 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
676 participants
Where
137 sitesin 24 countries
Study dates
26 Feb 2014to 29 Jun 2016
Phase
Phase 3
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

  • patients with moderate to severe plaque type psoriasis for at least 6 months before randomization
  • patients eligible for systemic therapy with inadequately controlled psoriasis

Who cannot join

  • forms of sporiasis other than plaque type psoriasis
  • previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

137 sites in 24 countries.

137 sites in 24 countries

United States26 sites

  • Novartis Investigative Site

    Arlington Heights, Illinois, 60005

  • Novartis Investigative Site

    Birmingham, Alabama, 35205

  • Novartis Investigative Site

    Boston, Massachusetts, 02111

  • Novartis Investigative Site

    Champaign, Illinois, 61820

  • Novartis Investigative Site

    Dallas, Texas, 75230

  • Novartis Investigative Site

    East Windsor, New Jersey, 08520

  • Novartis Investigative Site

    Forest Hills, New York, 11375

  • Novartis Investigative Site

    Greer, South Carolina, 29651

  • Novartis Investigative Site

    Hot Springs, Arkansas, 71913

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Los Angeles, California, 90045

  • Novartis Investigative Site

    Mobile, Alabama, 36608

  • Novartis Investigative Site

    Norfolk, Virginia, 23507

  • Novartis Investigative Site

    Oceanside, California, 92056

  • Novartis Investigative Site

    Overland Park, Kansas, 66215

  • Novartis Investigative Site

    Owensboro, Kentucky, 42301

  • Novartis Investigative Site

    Phoenix, Arizona, 85032

  • Novartis Investigative Site

    Portland, Oregon, 97210

  • Novartis Investigative Site

    Portland, Oregon, 97223

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    Santa Monica, California, 90404

  • Novartis Investigative Site

    Seattle, Washington, 98101

  • Novartis Investigative Site

    Skokie, Illinois, 60077

  • Novartis Investigative Site

    South Miami, Florida, 33143

  • Novartis Investigative Site

    St Louis, Missouri, 63117

Other trials in United States

Germany22 sites

  • Novartis Investigative Site

    Augsburg, 86179

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Berlin, 10783

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Bochum, 44803

  • Novartis Investigative Site

    Darmstadt, 64283

  • Novartis Investigative Site

    Dessau, 06847

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22391

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Kiel, 24148

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Münster, 48159

  • Novartis Investigative Site

    Pommelsbrunn, 91224

Other trials in Germany

Spain21 sites

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    Granada, Andalusia, 18012

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, Las Palmas de G.C, 35010

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28031

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valencia, Valencia, 46026

Other trials in Spain

United Kingdom8 sites

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD5 0NA

  • Novartis Investigative Site

    Coventry, CV2 2DX

  • Novartis Investigative Site

    Dundee, Perthshire, DD1 9SY

  • Novartis Investigative Site

    Harrogate, HG2 7SX

  • Novartis Investigative Site

    Hull, HU3 2JZ

  • Novartis Investigative Site

    Redhill, Surrey, RH1 5RH

  • Novartis Investigative Site

    Salford, Manchester, M6 8HD

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

France5 sites

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    La Rochelle, 17019

  • Novartis Investigative Site

    Martigues, 13500

  • Novartis Investigative Site

    Nice, 06202

Other trials in France

Netherlands5 sites

  • Novartis Investigative Site

    Breda, CK, 4818

  • Novartis Investigative Site

    Nijmegen, 6500 MB

  • Novartis Investigative Site

    Rotterdam, 3015 CE

  • Novartis Investigative Site

    Sneek, 8601 ZK

  • Novartis Investigative Site

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

Portugal5 sites

  • Novartis Investigative Site

    Coimbra, 3000-075

  • Novartis Investigative Site

    Lisbon, 1069-166

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

Australia4 sites

  • Novartis Investigative Site

    East Melbourne, Victoria, 3002

  • Novartis Investigative Site

    Phillip, Australian Capital Territory, 2606

  • Novartis Investigative Site

    Sydney, New South Wales, 2010

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Austria4 sites

  • Novartis Investigative Site

    Innsbruck, 6020

  • Novartis Investigative Site

    Linz, A-4020

  • Novartis Investigative Site

    Vienna, A-1030

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Bulgaria4 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1404

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Varna, 9000

Other trials in Bulgaria

Canada4 sites

  • Novartis Investigative Site

    Etobicoke, Ontario, M8X 1Y9

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 1V6

  • Novartis Investigative Site

    Mississauga, Ontario, L5H 1G9

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4X7

Other trials in Canada

Israel4 sites

  • Novartis Investigative Site

    Afula, 1834111

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Tel Aviv, 6209804

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Slovakia4 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovak Republic, 97401

  • Novartis Investigative Site

    Bojnice, 972 01

  • Novartis Investigative Site

    Košice, 04001

  • Novartis Investigative Site

    Kosice-Saca, Slovak Republic, 040 15

Other trials in Slovakia

Belgium3 sites

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Namur, 5000

Other trials in Belgium

Italy3 sites

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

South Korea3 sites

  • Novartis Investigative Site

    Gwangju, 501-757

  • Novartis Investigative Site

    Seoul, Korea, 03722

  • Novartis Investigative Site

    Seoul, Korea, 06351

Other trials in South Korea

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Szeged, H-6725

Other trials in Hungary

Taiwan2 sites

  • Novartis Investigative Site

    Linkou District, 33305

  • Novartis Investigative Site

    Taipei, 10002

Other trials in Taiwan

Turkey (Türkiye)2 sites

  • Novartis Investigative Site

    Balcova / Izmir, 35340

  • Novartis Investigative Site

    Bursa, 16059

Other trials in Turkey (Türkiye)

Denmark1 site

  • Novartis Investigative Site

    Arhus C, DK-8000

Other trials in Denmark

Greece1 site

  • Novartis Investigative Site

    Heraklion, Crete, GR, 71110

Other trials in Greece

Norway1 site

  • Novartis Investigative Site

    Bergen, NO-5021

Other trials in Norway

Switzerland1 site

  • Novartis Investigative Site

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)

This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis

Being tested
AIN457 300 mg, ustekinumab 45/90 mg, placebo secukinumab
Keywords
chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling
Medical subject headings
Dermatitis

What participants receive

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

  • AIN457 300 mgDrug

    Also called secukinumab

  • ustekinumab 45/90 mgDrug

  • placebo secukinumabDrug

    Placebo

Study groups in NCT02074982
Study groupRoleWhat they receive
AIN457 300 mgExperimentalpatients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
Receives: Drug: AIN457 300 mg
UstekinumabActive comparatorpatients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Receives: Drug: ustekinumab 45/90 mg; Drug: placebo secukinumab

What is being measured

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

  1. Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16

    Psoriasis Area and Severity Index (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).

    PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16

    Measured: Week 16

Secondary outcomes (2)

  1. Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4

    Psoriasis Area and Severity Index (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).

    Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4

    Measured: Week 4

  2. Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52

    Psoriasis Area and Severity Index (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).

    PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52

    Measured: Week 52

Timeline

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

  1. First posted3 Mar 2014 (estimated)
  2. Study start26 Feb 2014
  3. Primary completion29 Jun 2016
  4. Study completion29 Jun 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02074982
Sponsor's protocol ID
CAIN457A2317
Other IDs
2013-003434-32
Status last verified
Jun 2017
First submitted
27 Feb 2014
Last updated
21 Jul 2017
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

  • Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.

    PubMed 36334236

  • Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

    PubMed 35305260

  • Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.

    PubMed 34870789

  • Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.

    PubMed 30972746

  • Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.

    PubMed 26092291

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AIN457 300 mg and ustekinumab 45/90 mg in people with Chronic Plaque Type Psoriasis, run by Novartis Pharmaceuticals at 137 sites in 24 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 2 inclusion and 3 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Germany, Spain, United Kingdom, France and 19 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Jul 2017). 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 With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (time frame: 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 NCT02074982, which also lists 5 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 21 Jul 2017.

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