PsoriasisPhase 3ECLIPSENCT03090100
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
A Phase 3 study testing Guselkumab and Secukinumab in people with Psoriasis, run by Janssen Research & Development, LLC at 142 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Guselkumab and Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,048 participants
- Where
- 142 sitesin 9 countries
- Study dates
- 27 Apr 2017to 20 Sep 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
- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug
- A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
- Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
- Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study
Who cannot join
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has previously received guselkumab or secukinumab
- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
Trial locations and contacts
142 sites in 9 countries.
142 sites in 9 countries
United States44 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, 30022
Advanced Medical Research
Atlanta, Georgia, 30328
Austin Dermatology Associates
Austin, Texas, 78705
Great Lakes Research Group
Bay City, Michigan, 48706
Dermatologists of Greater Columbus
Bexley, Ohio, 43209
University of Alabama Birmingham
Birmingham, Alabama, 35233
Olympian Clinical Research
Clearwater, Florida, 33757
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134
Modern Research Associates
Dallas, Texas, 75231
Menter Dermatology Research Institute
Dallas, Texas, 75246-1615
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810
Henry Ford Medical Center
Detroit, Michigan, 49202
Windsor Dermatology
East Windsor, New Jersey, 08520-2505
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
The Ohio State University
Gahanna, Ohio, 43230
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Suzanne Bruce and Associates - The Center for Skin Research
Houston, Texas, 77056-4132
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Clinical Partners
Johnston, Rhode Island, 02919
Southern California Permanente Medical Group
Los Angeles, California, 90027
Dermatology Specialists
Louisville, Kentucky, 40241
Marietta Dermatology Clinical Research
Marietta, Georgia, 30060
Virginia Clinical Research
Norfolk, Virginia, 23322
Central Sooner Research
Norman, Oklahoma, 73071
Renstar Medical Research
Ocala, Florida, 34470
Dermatology Specialists
Oceanside, California, 92056
Park Avenue Dermatology
Orange Park, Florida, 32073
University of Pittsburgh Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
DermAssociates, PC
Rockville, Maryland, 20850
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Progressive Clinical Research
San Antonio, Texas, 78213
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
MedDerm Associates
San Diego, California, 92103
San Luis Dermatology & Laser Clinic, Inc
San Luis Obispo, California, 93405
Southern California Dermatology
Santa Ana, California, 92701
Dermatology Associates of Seattle
Seattle, Washington, 98101-1498
Northshore Universite Healthsystem
Skokie, Illinois, 60077
Central Dermatology
St Louis, Missouri, 63117
Somerset Skin Centre
Troy, Michigan, 48084
Germany17 sites
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
Berlin, 10117
ISA GmbH
Berlin, 10789
Universitatsklinikum Bonn
Bonn, 53105
Klinische Forschung Dresden GmbH
Dresden, 01069
University Hospital Dresden
Dresden, 01307
Universitatsklinikum Essen
Essen, 45122
Universitatsklinikum Frankfurt
Frankfurt am Main, 60590
Universitaetsklinik Hamburg-Eppendorf
Hamburg, 20246
SCIderm GmbH
Hamburg, 20354
MensingDerma research GmbH
Hamburg, 22391
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, 24105
Universitaetsklinik Luebeck
Lübeck, 23538
Hautarztpraxis
Mahlow, 15831
Technische Universitaet Muenchen
München, 80802
Universitaetsklinikum Muenster
Münster, 48149
Universitaetsklinik Tuebingen
Tübingen, 72076
Centrovital
Witten, 58453
Poland16 sites
NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik
Bialystok, 15-351
Specderm Poznańska sp. j.
Bialystok, 15-375
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
Bydgoszcz, 85-094
Centrum Kliniczno Badawcze
Elblag, 82-300
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk, 80-298
Malopolskie Centrum Medyczne
Krakow, 30-510
Centrum Badawcze Wspolczesnej Terapii
Lodz, 90-242
Dermed Centrum Medyczne Sp. z o.o
Lodz, 90-265
Solumed S.C.
Poznan, 60-529
CRC Sp. z o.o.
Poznan, 60-848
Lubelskie Centrum Diagnostyczne
Świdnik, 21-040
NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm
Torun, 87-100
Przychodnia Specjalistyczna High-Med
Warsaw, 01-817
Wojskowy Instytut Medyczny
Warsaw, 04-141
DermMedica Sp. z o.o.
Wroclaw, 51-318
Centrum Medyczne WroMedica
Wroclaw, 51-685
Spain15 sites
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922
Hosp. Gral. Univ. de Alicante
Alicante, 03010
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp. Univ. de Cruces
Barakaldo, 48903
Hosp. Del Mar
Barcelona, 08003
Hosp. de La Santa Creu I Sant Pau
Barcelona, 8041
Hosp. Univ. de Basurto
Bilbao Vizcaya, 48009
Hosp. Reina Sofia
Córdoba, 14004
Hosp. Univ. Infanta Leonor
Madrid, 28031
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. La Paz
Madrid, 28046
Hosp. Univ. de Torrejon
Madrid, 28850
Hosp. de Manises
Manises, 46940
Hosp. Provincial de Pontevedra
Pontevedra, 36003
Hosp. Univ. I Politecni La Fe
Valencia, 046026
Canada14 sites
CCA Medical Research Corporation
Ajax, L1S7K8
Stratica Medical
Edmonton, T5K 1X3
Eastern Canada Research Associates
Halifax, B3H 1Z2
Dermatrials Research
Hamilton, Ontario, L8N 1Y2
Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
DermEdge Research
Mississauga, L5H 1G9
Innovaderm Research
Montreal, H2K4L5
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Centre Dermatologique
Québec, G1V 4X7
Dr. Chih-ho Hong Medical
Surrey, V3R 6A7
Toronto Research Centre
Toronto, Ontario, M3H5Y8
K. Papp Clinical Research
Waterloo, N2J 1C4
XLR8 Medical Research
Windsor, N8W 1E6
Australia11 sites
The Skin Centre
Benowa, 4217
Sinclair Dermatology
East Melbourne, 3002
Fremantle Dermatology
Fremantle, 6160
Clinical Trials SA Pty Ltd
Hectorville, 5073
Premier Specialists
Kogarah, 2217
St George Dermatology & Skin Cancer Centre
Kogarah, 2217
Skin&Cancer Foundation Inc
Melbourne, 3053
Royal Melbourne Hospital
Parkville, 3050
Westmead Hospital
Westmead, 2145
Woden Dermatology
Woden, 2606
Veracity Clinical Research
Woolloongabba, 4102
Hungary9 sites
Semmelweis Egyetem
Budapest, 1085
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Somogy Megyei Kaposi Mor Oktatokorhaz
Kaposvár, 7400
Bacs-kiskun Megyei Korhaz
Kecskemét, 6000
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3529
Pecsi Tudomanyegyetem
Pécs, 7632
Szegedi Tudomanyegyetem
Szeged, 6720
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprém, 8200
Czechia8 sites
Nemocnice Jihlava
Jihlava, 586 33
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, 248 01
DERMAMEDICA s.r.o.
Náchod, 547 01
Nemocnice Novy Jicin a.s.
Nový Jičín, 741 01
Fakultni nemocnice Ostrava
Ostrava- Poruba, 708 52
Fakultni nemocnice Kralovske Vinohrady
Prague, 775 20
Dermatologicka ambulance
Svitavy, 568 02
Masarykova nemocnice v Usti nad Labem
Ústí nad Labem
France8 sites
CHU Bordeaux - Hopital St Andre
Bordeaux, 33000
ICH Hopital A. Morvan
Brest, 29200
Groupe Hospitalier La Rochelle - Re - Aunis
La Rochelle, 17019
Le Bateau Blanc
Martigues, 13500
CHU Nantes - Hotel Dieu
Nantes, 44093
CHU de Nice Hopital de l Archet
Nice, 06200
Hopital Charles Nicolle
Rouen, 76031
Hopital Larrey CHU de Toulouse
Toulouse, 31000
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
Read the detailed description
The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.
- Conditions
- Psoriasis
- Being tested
- Guselkumab, Placebo, Secukinumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
PlaceboDrug
Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
SecukinumabDrug
Also called Cosentyx
Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Guselkumab Plus Placebo | Experimental | Participants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind. Receives: Drug: Guselkumab; Drug: Placebo |
| Group II: Secukinumab | Active comparator | Participants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Measured: Week 48
Secondary outcomes (17)
Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Measured: Week 12 and 48
Percentage of Participants Who Achieved a PASI-90 Response at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
Measured: Week 12
Percentage of Participants Who Achieved a PASI-75 Response at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Measured: Week 12
Percentage of Participants Who Achieved a PASI-100 Response at Week 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.
Measured: Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Measured: Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Measured: Week 48
Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Measured: Week 16 and 48
Percentage of Participants Who Achieved a PASI-75 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Measured: Week 16
Percentage of Participants Who Achieved a PASI-90 Response at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Measured: Week 16
Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.
Measured: Week 24 up to Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Measured: Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Measured: Week 12
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Measured: Week 48
Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.
Measured: Week 48
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.
Measured: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Percentage of Participants With IGA Responses Through Week 56
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Measured: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Percent Improvement From Baseline in PASI Through Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Measured: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start27 Apr 2017
- Primary completion2 Aug 2018
- Study completion20 Sep 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 PsoriasisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090100
- Sponsor's protocol ID
- CR108278
- Other IDs
- 2016-002995-29, CNTO1959PSO3009, 2016
- Acronym
- ECLIPSE
- Status last verified
- Sep 2019
- First submitted
- 22 Mar 2017
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Blauvelt A, Chen Y, Branigan PJ, Liu X, DePrimo S, Keyes BE, Leung M, Fakharzadeh S, Yang YW, Munoz-Elias EJ, Krueger JG, Langley RG. Differential Pharmacodynamic Effects on Psoriatic Biomarkers by Guselkumab Versus Secukinumab Correlate with Long-Term Efficacy: An ECLIPSE Substudy. JID Innov. 2024 Jun 26;4(5):100297. doi: 10.1016/j.xjidi.2024.100297. eCollection 2024 Sep.
PubMed 39224116Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15.
PubMed 38485863Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
PubMed 37906417Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8.
PubMed 31402114
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT03090100
- Acronym / sponsor ID
- ECLIPSE / CR108278
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,048 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
Detailed description
The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Guselkumab Plus Placebo | Experimental | Drug: Guselkumab, Drug: PlaceboParticipants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind. |
| Group II: Secukinumab | Active comparator | Drug: SecukinumabParticipants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug
- A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
- Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
- Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study
Key exclusion criteria (5 listed)
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has previously received guselkumab or secukinumab
- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
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 |
|---|---|---|
| GuselkumabParticipants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44. | Drug | Group I: Guselkumab Plus Placebo |
| PlaceboParticipants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40. | Drug | Group I: Guselkumab Plus Placebo |
| SecukinumabAlso: CosentyxParticipants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. | Drug | Group II: Secukinumab |
Primary outcome
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
Time frame: Week 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
17 secondary outcomes
Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
Time frame: Week 12 and 48
Percentage of Participants Who Achieved a PASI-90 Response at Week 12
Time frame: Week 12
Percentage of Participants Who Achieved a PASI-75 Response at Week 12
Time frame: Week 12
Percentage of Participants Who Achieved a PASI-100 Response at Week 48
Time frame: Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
Time frame: Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
Time frame: Week 48
Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
Time frame: Week 16 and 48
Percentage of Participants Who Achieved a PASI-75 Response at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved a PASI-90 Response at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
Time frame: Week 24 up to Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
Time frame: Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
Time frame: Week 12
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
Time frame: Week 48
Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
Time frame: Week 48
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
Time frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Percentage of Participants With IGA Responses Through Week 56
Time frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Percent Improvement From Baseline in PASI Through Week 56
Time frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39224116Blauvelt A, Chen Y, Branigan PJ, Liu X, DePrimo S, Keyes BE, Leung M, Fakharzadeh S, Yang YW, Munoz-Elias EJ, Krueger JG, Langley RG. Differential Pharmacodynamic Effects on Psoriatic Biomarkers by Guselkumab Versus Secukinumab Correlate with Long-Term Efficacy: An ECLIPSE Substudy. JID Innov. 2024 Jun 26;4(5):100297. doi: 10.1016/j.xjidi.2024.100297. eCollection 2024 Sep.
- Derived from this study: PubMed 38485863Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15.
- Derived from this study: PubMed 37906417Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
- Derived from this study: PubMed 31402114Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
142 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guselkumab and Secukinumab in people with Psoriasis, run by Janssen Research & Development, LLC at 142 sites in 9 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 5 inclusion and 5 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 142 sites in United States, Germany, Poland, Spain, Canada and 4 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 1 Oct 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?
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (time frame: Week 48). 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 NCT03090100, 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 1 Oct 2019.