Trial record 1 of 7 for:
frontier 1 | Plaque Psoriasis
A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis (FRONTIER 1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05223868 |
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Recruitment Status :
Completed
First Posted : February 4, 2022
Last Update Posted : January 5, 2024
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: JNJ-77242113 Drug: Placebo | Phase 2 |
The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and psoriatic arthritis (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 255 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis |
| Actual Study Start Date : | February 3, 2022 |
| Actual Primary Completion Date : | December 15, 2022 |
| Actual Study Completion Date : | December 15, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo
Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
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Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. Drug: Placebo Placebo tablet will be administered orally. |
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Experimental: Group 2: JNJ-77242113 Dose 2 QD and Placebo
Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
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Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. Drug: Placebo Placebo tablet will be administered orally. |
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Experimental: Group 3: JNJ-77242113 Dose 3 QD and Placebo
Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
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Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. Drug: Placebo Placebo tablet will be administered orally. |
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Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo
Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
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Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. Drug: Placebo Placebo tablet will be administered orally. |
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Experimental: Group 5: JNJ-77242113 Dose 3 BID and Placebo
Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
|
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally. Drug: Placebo Placebo tablet will be administered orally. |
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Placebo Comparator: Group 6: Placebo
Participants will receive placebo BID from Week 0 through Week 16.
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Drug: Placebo
Placebo tablet will be administered orally. |
Primary Outcome Measures :
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16 [ Time Frame: Week 16 ]Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percentage [%] improvement from baseline in PASI) at Week 16 will be 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 and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
Secondary Outcome Measures :
- Change from Baseline in PASI Total Score at Week 16 [ Time Frame: From baseline to Week 16 ]Change from baseline in PASI total score at Week 16 will be reported.
- Percentage of Participants Achieving PASI 90 Score at Week 16 [ Time Frame: Week 16 ]Percentage of participants achieving PASI 90 score (>=90% improvement from baseline in PASI) at Week 16 will be reported.
- Percentage of Participants Achieving PASI 100 Score at Week 16 [ Time Frame: Week 16 ]Percentage of participants achieving PASI 100 score (100% improvement from baseline in PASI) at Week 16 will be reported.
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. 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).
- Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16 [ Time Frame: Week 16 ]Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported.
- Change from Baseline in Body Surface Area (BSA) at Week 16 [ Time Frame: From baseline to Week 16 ]Change from baseline in BSA at Week 16 will be reported. Body Surface Area is a commonly used measure of severity of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis).
- Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16 [ Time Frame: From baseline to Week 16 ]Change from baseline in PSSD symptoms scores at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Change from Baseline in PSSD Signs Score at Week 16 [ Time Frame: From baseline to Week 16 ]Change from baseline in PSSD signs score at Week 16 will be reported.
- Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 16 in Participants with a Baseline Symptoms Score >=1 [ Time Frame: Week 16 ]Percentage of participants achieving PSSD symptoms score=0 at Week 16 in participants with a baseline symptoms score >=1 will be reported.
- Percentage of Participants Achieving PSSD Sign Score=0 at Week 16 in Participants with a Baseline Sign Score >=1 [ Time Frame: Week 16 ]Percentage of participants achieving PSSD sign score=0 at Week 16 in participants with a baseline sign score >=1 will be reported.
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 in Participants with Baseline DLQI Score >1 [ Time Frame: Week 16 ]The DLQI is a dermatology-specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past 7 days and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.
- Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score at Week 16 [ Time Frame: From baseline to Week 16 ]Change from baseline in PROMIS-29 domain scores at week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL instrument assessing 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. These questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.
- Percentage of Participants Who Achieve >= 5-Point Improvement from Baseline in PROMIS-29 Domain Score at Week 16 [ Time Frame: Week 16 ]Percentage of participants who achieve >=5-point improvement from baseline in PROMIS-29 domain score at Week 16 will be reported.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 24 weeks ]An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 24 weeks ]SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
- Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
- Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
- Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline
Exclusion Criteria:
- Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
- Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor [TNF]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
- Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05223868
Locations
Show 76 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT05223868 |
| Other Study ID Numbers: |
CR109138 2021-003700-41 ( EudraCT Number ) 77242113PSO2001 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | February 4, 2022 Key Record Dates |
| Last Update Posted: | January 5, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |