PsoriasisPhase 3NCT02905331
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
A Phase 3 study testing Guselkumab in people with Psoriasis, run by Janssen Research & Development, LLC at 14 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 28 Feb 2017to 6 Feb 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
- A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0
- Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)
- Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
- Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 at screening and at baseline
- Have an involved body surface area (BSA) >= 10 percent (%) at screening and at baseline
Who cannot join
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug)
- Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
- Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States8 sites
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Clinical Partners
Johnston, Rhode Island, 02919
Dermatology Specialists
Louisville, Kentucky, 40241
Virginia Clinical Research
Norfolk, Virginia, 23502
Renstar Medical Research
Ocala, Florida, 34470
University of Pittsburgh Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Canada3 sites
Dermatrials Research
Hamilton, Ontario, L8N 1Y2
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Dr. Chih ho Hong Medical
Surrey, British Columbia, V3R 6A7
Poland3 sites
Niepubliczny Zaklad Opieki Zdrowotnej Osteo-Medic s.c. Artur Racewicz i Jerzy Supronik
Bialystok, 15 351
Szpital Uniwersytecki nr 1 im Dr A Jurasza
Bydgoszcz, 85 094
Wromedica Irena Bielicka, Janusz Szczepanik S.C.
Wroclaw, 51-685
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
- Conditions
- Psoriasis
- Being tested
- Guselkumab, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called CNTO 1959
Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.
PlaceboDrug
Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Guselkumab: Placebo) | Experimental | Participants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind. Receives: Drug: Guselkumab; Drug: Placebo |
| Group 2 (Placebo: Guselkumab) | Experimental | Partcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28. Receives: Drug: Guselkumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA documents the investigator's assessment of the participants 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). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.
Measured: Week 16
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (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 percent (%) to 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 can range from 0 (no psoriasis) 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. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Measured: Week 16
Secondary outcomes (8)
Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16
The IGA documents the investigator's assessment of the participants 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). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Measured: Week 16
Percentage of Participants Who Achieve a PASI 100 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Measured: Week 16
Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16
The IGA documents the investigator's assessment of the participants 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). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Measured: Week 16
Percentage of Participants Who Achieve a PASI 50 Response and 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with >=50% and >= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
Measured: Week 16
Percent Improvement From Baseline in PASI Score 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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.
Measured: Baseline and Week 16
Percent Improvement From Baseline in PASI Score Through Week 40
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% to 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 can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Measured: Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
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). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Measured: Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
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. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.
Measured: Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start28 Feb 2017
- Primary completion6 Feb 2018
- Study completion6 Feb 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 (2)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
- 78 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
- NCT02905331
- Sponsor's protocol ID
- CR108203
- Other IDs
- CNTO1959PSO3006, 2016-002022-37, 2016
- Status last verified
- Jan 2025
- First submitted
- 14 Sep 2016
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Strober 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 37906417Ferris LK, Ott E, Jiang J, Hong HC, Li S, Han C, Baran W. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020 Mar;31(2):152-159. doi: 10.1080/09546634.2019.1587145. Epub 2019 Mar 19.
PubMed 30887876
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
- ClinicalTrials.gov ID
- NCT02905331
- Acronym / sponsor ID
- CR108203
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 6 Sep 2018
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 the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Guselkumab: Placebo) | Experimental | Drug: Guselkumab, Drug: PlaceboParticipants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind. |
| Group 2 (Placebo: Guselkumab) | Experimental | Drug: Guselkumab, Drug: PlaceboPartcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0
- Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)
- Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
- Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 at screening and at baseline
- Have an involved body surface area (BSA) >= 10 percent (%) at screening and at baseline
Key exclusion criteria (5 listed)
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug)
- Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
- Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug
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 |
|---|---|---|
| GuselkumabAlso: CNTO 1959Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device. | Drug | Group 1 (Guselkumab: Placebo), Group 2 (Placebo: Guselkumab) |
| PlaceboParticipants will receive matching placebo supplied in a PFS assembled in a SelfDose device. | Drug | Group 1 (Guselkumab: Placebo), Group 2 (Placebo: Guselkumab) |
Primary outcome
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Time frame: Week 16
The IGA documents the investigator's assessment of the participants 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). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Time frame: 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 percent (%) to 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 can range from 0 (no psoriasis) 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. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
8 secondary outcomes
Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16
Time frame: Week 16
Percentage of Participants Who Achieve a PASI 100 Response at Week 16
Time frame: Week 16
Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16
Time frame: Week 16
Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16
Time frame: Week 16
Percent Improvement From Baseline in PASI Score at Week 16
Time frame: Baseline and Week 16
Percent Improvement From Baseline in PASI Score Through Week 40
Time frame: Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)
Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40
Time frame: Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 30887876Ferris LK, Ott E, Jiang J, Hong HC, Li S, Han C, Baran W. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020 Mar;31(2):152-159. doi: 10.1080/09546634.2019.1587145. Epub 2019 Mar 19.
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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
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guselkumab in people with Psoriasis, run by Janssen Research & Development, LLC at 14 sites in 3 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Poland. 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 6 Sep 2018). 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 an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (time frame: Week 16). 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 NCT02905331, which also lists 2 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 4 Feb 2025.