Plaque PsoriasisPhase 3CLARITYNCT02826603
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
A Phase 3 study testing Secukinumab and Ustekinumab in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 154 sites in 11 countries.
Trial summary
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis. 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 and Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,114 participants
- Where
- 154 sitesin 11 countries
- Study dates
- 22 Jun 2016to 9 Jul 2018
- 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
- Subjects must give a written, signed and dated informed consent
- Chronic plaque-type psoriasis present for at least 6 months before randomization
- Moderate to severe plaque psoriasis as defined at randomization by:
- PASI score of ≥12 and
- Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
- IGA mod 2011 ≥3 (based on a scale of 0-4)
Show all 10Show fewer
- Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
- Topical treatment (including topical corticosteroids) and/or
- Phototherapy and/or
- Previous systemic therapy
Who cannot join
- Forms of psoriasis other than plaque psoriasis
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
- Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
154 sites in 11 countries.
154 sites in 11 countries
United States123 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87106
Novartis Investigative Site
Alpharetta, Georgia, 30022
Novartis Investigative Site
Anderson, South Carolina, 29621
Novartis Investigative Site
Anniston, Alabama, 36207
Novartis Investigative Site
Arlington, Texas, 76011
Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Austin, Texas, 78705
Novartis Investigative Site
Aventura, Florida, 33180
Novartis Investigative Site
Bakersfield, California, 93309
Novartis Investigative Site
Baton Rouge, Louisiana, 70809
Novartis Investigative Site
Beverly, Massachusetts, 01915
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Boca Raton, Florida, 33486
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Brighton, Massachusetts, 02135
Novartis Investigative Site
California City, California, 93405
Novartis Investigative Site
Cape Coral, Florida, 33990
Novartis Investigative Site
Chapel Hill, North Carolina, 27516
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Charlotte, North Carolina, 28209
Novartis Investigative Site
Cincinnati, Ohio, 45242
Novartis Investigative Site
Cleveland, Ohio, 44106-5028
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Coral Gables, Florida, 33134
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Denver, Colorado, 80220
Novartis Investigative Site
Dublin, Ohio, 43016
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
East Windsor, New Jersey, 08520
Novartis Investigative Site
Encinitas, California, 92024
Novartis Investigative Site
Everett, Washington, 98201
Novartis Investigative Site
Exton, Pennsylvania, 19341
Novartis Investigative Site
Fairborn, Ohio, 45324
Novartis Investigative Site
Forest Hills, New York, 11375
Novartis Investigative Site
Fort Myers, Florida, 33916
Novartis Investigative Site
Fort Smith, Arkansas, 72916
Novartis Investigative Site
Fresno, California, 93710
Novartis Investigative Site
Fridley, Minnesota, 55432
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Glendale, Arizona, 85308
Novartis Investigative Site
Goodlettsville, Tennessee, 37072-2301
Novartis Investigative Site
Greensboro, North Carolina, 27401
Novartis Investigative Site
Greer, South Carolina, 29651
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Hot Springs, Arkansas, 71913
Novartis Investigative Site
Houston, Texas, 77056
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Irvine, California, 92697
Novartis Investigative Site
Jackson, Mississippi, 39216-4505
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Jenkintown, Pennsylvania, 19046
Novartis Investigative Site
Knoxville, Tennessee, 37922
Novartis Investigative Site
Lake Charles, Louisiana, 70601
Novartis Investigative Site
Lake Charles, Louisiana, 70605
Novartis Investigative Site
Las Vegas, Nevada, 89128
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Louisville, Kentucky, 40241
Novartis Investigative Site
Macon, Georgia, 31217
Novartis Investigative Site
Madison, Wisconsin, 53717
Novartis Investigative Site
Marietta, Georgia, 30060
Novartis Investigative Site
Metairie, Louisiana, 70006
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Murfreesboro, Tennessee, 37130
Novartis Investigative Site
Murray, Utah, 84107
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
New Albany, Indiana, 47150
Novartis Investigative Site
New Orleans, Louisiana, 70112
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
New York, New York, 10025 1737
Novartis Investigative Site
New York, New York, 10075
Novartis Investigative Site
Newnan, Georgia, 30263
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Oklahoma City, Oklahoma, 73103
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Orange Park, Florida, 32073
Novartis Investigative Site
Oregon City, Oregon, 97045
Novartis Investigative Site
Owensboro, Kentucky, 42301
Novartis Investigative Site
Owensboro, Kentucky, 42303
Novartis Investigative Site
Pflugerville, Texas, 78660
Novartis Investigative Site
Phoenix, Arizona, 85018
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213-3403
Novartis Investigative Site
Plymouth Meeting, Pennsylvania, 19462
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Portland, Oregon, 97223
Novartis Investigative Site
Quincy, Massachusetts, 02169
Novartis Investigative Site
Rochester, New York, 14623
Novartis Investigative Site
Rockville, Maryland, 20850
Novartis Investigative Site
Rockville, Maryland, 20852
Novartis Investigative Site
Rocky Mount, North Carolina, 27804
Novartis Investigative Site
Rogers, Arkansas, 72758
Novartis Investigative Site
Sacramento, California, 95819
Novartis Investigative Site
Saint Joseph, Missouri, 64506
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Diego, California, 92103
Novartis Investigative Site
San Diego, California, 92117
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Santa Monica, California, 90404
Novartis Investigative Site
Santa Rosa, California, 95405
Novartis Investigative Site
Scottsdale, Arizona, 85259
Novartis Investigative Site
Scottsdale, Arizona, 85260
Novartis Investigative Site
Seattle, Washington, 98101
Novartis Investigative Site
Skokie, Illinois, 60077
Novartis Investigative Site
South Miami, Florida, 33143
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
St Louis, Missouri, 63104
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Tampa, Florida, 33609
Novartis Investigative Site
Tampa, Florida, 33624
Novartis Investigative Site
Trumbull, Connecticut, 06611
Novartis Investigative Site
Tucson, Arizona, 85724
Novartis Investigative Site
Verona, New Jersey, 07044
Novartis Investigative Site
Walla Walla, Washington, 99362
Novartis Investigative Site
Wenatchee, Washington, 98801
Novartis Investigative Site
West Palm Beach, Florida, 33409
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
Poland7 sites
Novartis Investigative Site
Gdansk, 80-803
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Lodz, 90-436
Novartis Investigative Site
Olsztyn, 10-045
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Warsaw, 02-097
Novartis Investigative Site
Warsaw, 02-507
South Korea6 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Canada4 sites
Novartis Investigative Site
Etobicoke, Ontario, M8X 1Y9
Novartis Investigative Site
Hamilton, Ontario, L8N 1V6
Novartis Investigative Site
Sainte-Hyacinthe, Quebec, J2S 66
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1A 5E8
Hungary3 sites
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Pécs, 7632
Novartis Investigative Site
Szeged, 6725
Czechia2 sites
Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Prague, 100 34
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01015
Malaysia2 sites
Novartis Investigative Site
Johor Bahru, 80100
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
Slovakia2 sites
Novartis Investigative Site
Bojnice, 972 01
Novartis Investigative Site
Košice, Slovak Republic, 040 15
Vietnam2 sites
Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Ho Chi Minh City, 7000
About this study
Official title: A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Secukinumab, Ustekinumab
- Keywords
- Plaque psoriasis, secukinumab, ustekinumab, ain457, ain457a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
UstekinumabDrug
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Secukinumab Receives: Drug: Secukinumab |
| Ustekinumab | Active comparator | Ustekinumab Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
Number of participants who achieved ≥ 90% reduction in PASI compared to baseline.
Logistic regression analysis of PASI 90 response at Week 12
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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).
Measured: Week 12
Participants With IGA Mod 2011 0 or 1 at Week 12
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Measured: Week 12
Secondary outcomes (8)
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.
Measured: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.
Measured: Week 4
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16
Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.
Measured: Week 16
Participants With IGA Mod 2011 0 or 1 at 16 Weeks
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Measured: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12
Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.
Measured: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.
Measured: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.
Measured: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52
Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start22 Jun 2016
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
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 (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,114 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
- NCT02826603
- Sponsor's protocol ID
- CAIN457A2326
- Other IDs
- 2015-002898-37, 2015
- Acronym
- CLARITY
- Status last verified
- Jun 2019
- First submitted
- 30 Nov 2015
- Last updated
- 9 Jul 2019
- 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
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 36334236Conrad 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 34870789Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.
PubMed 32365251Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.
PubMed 30334147
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02826603
- Acronym / sponsor ID
- CLARITY / CAIN457A2326
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque psoriasis, secukinumab, ustekinumab, ain457, ain457a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.
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 | Drug: SecukinumabSecukinumab |
| Ustekinumab | Active comparator | Drug: UstekinumabUstekinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must give a written, signed and dated informed consent
- Chronic plaque-type psoriasis present for at least 6 months before randomization
- Moderate to severe plaque psoriasis as defined at randomization by:
- Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
Key exclusion criteria (7 listed)
- Forms of psoriasis other than plaque psoriasis
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
- Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
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 |
|---|---|---|
| Secukinumab300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48 | Drug | Secukinumab |
| UstekinumabPer approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections. | Drug | Ustekinumab |
Primary outcome
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
Time frame: Week 12
Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).
Participants With IGA Mod 2011 0 or 1 at Week 12
Time frame: Week 12
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
8 secondary outcomes
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Time frame: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Time frame: Week 4
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16
Time frame: Week 16
Participants With IGA Mod 2011 0 or 1 at 16 Weeks
Time frame: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12
Time frame: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Time frame: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Time frame: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36334236Alpalhao 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.
- Derived from this study: PubMed 34870789Conrad 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.
- Derived from this study: PubMed 32365251Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.
- Derived from this study: PubMed 30334147Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
154 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab and Ustekinumab in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 154 sites in 11 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 10 inclusion and 7 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 154 sites in United States, Poland, South Korea, Canada, Hungary and 6 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 9 Jul 2019). 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?
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (time frame: Week 12). 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 NCT02826603, which also lists 4 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 9 Jul 2019.