Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis (SPECTREM)
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06039189 |
|
Recruitment Status :
Recruiting
First Posted : September 15, 2023
Last Update Posted : April 24, 2024
|
Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Moderate Plaque Psoriasis | Drug: Guselkumab Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement |
| Actual Study Start Date : | August 24, 2023 |
| Estimated Primary Completion Date : | April 28, 2025 |
| Estimated Study Completion Date : | May 26, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information
available for:
Guselkumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1: Guselkumab
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
|
Drug: Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Names:
Drug: Placebo Placebo will be administered as subcutaneous injection. |
|
Placebo Comparator: Group 2: Placebo
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
|
Drug: Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Names:
Drug: Placebo Placebo will be administered as subcutaneous injection. |
Primary Outcome Measures :
- Percentage of Participants who Achieve 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 participant's psoriasis. 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).
Secondary Outcome Measures :
- Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16 [ Time Frame: Baseline, Week 16 ]Change from baseline in BSA affected with psoriasis at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).
- Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16 [ Time Frame: Baseline, Week 16 ]Change from baseline in PASI score 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Percentage of Participants who Achieve an Investigator's Global Assessment (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. The IGA documents the investigator's assessment of the participant's psoriasis. 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 who Achieve a PASI 90 Response at Week 16 [ Time Frame: Week 16 ]Percentage of participants who achieve a PASI 90 response 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline.
- Percentage of Participants who Achieve a PASI 100 Response at Week 16 [ Time Frame: Week 16 ]Percentage of participants who achieve a PASI 100 response 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.
- Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline [ Time Frame: Week 16 ]Percentage of participants who achieve a ss-IGA score of absence of disease (0) or very mild disease (1) at Week 16 among participants with an ss-IGA score >=3 at baseline will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. Scalp lesions are graded for induration, erythema, and scaling. The participant's scalp psoriasis is assessed as absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), or severe disease (4).
- Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline [ Time Frame: Week 16 ]Percentage of participants who achieve a sPGA-G score of clear (0) or minimal (1) at Week 16 among participants with a sPGA-G score >=3 at baseline will be reported. The sPGA-G is used to evaluate the disease severity of genital psoriasis. Severity of genital psoriasis is determined by a combination of 3 plaque characteristics: erythema, elevation, and scale. The participant's severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
- Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline [ Time Frame: Week 16 ]Percentage of participants who achieve an i-IGA score of clear (0) or minimal (1) at Week 16 among participants with an i-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment has been adapted with descriptions of disease features that are more consistent with intertriginous psoriasis presentation. The intertriginous areas affected to be scored include the axillary, sub-mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The participant's intertriginous areas affected are assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
- Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline [ Time Frame: Week 16 ]Percentage of participants who achieve a f-IGA score of clear (0) or minimal (1) at Week 16 among participants with an f-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment will be adapted for use, but only the face will be scored. The participant's facial psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
- Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16 [ Time Frame: Baseline, Week 16 ]Change from baseline in PSSD total symptom score at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline [ Time Frame: Week 16 ]Percentage of participants who achieve >=4 point reduction (improvement) in PSSD itch score from baseline at Week 16 among participants with a PSSD itch score >=4 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline [ Time Frame: Week 16 ]Percentage of participants with PSSD individual symptom score of 0 at Week 16 among participants with PSSD >0 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Week 56 ]Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to Week 56 ]Number of participants with SAEs will be reported. A SAE is any untoward medical occurrence that may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
- All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3
- All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
- All participants be a candidate for phototherapy or systemic treatment for psoriasis
Exclusion Criteria:
- Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
- 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)
- For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
- Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
- Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
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): NCT06039189
Contacts
| Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Locations
Show 64 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: | NCT06039189 |
| Other Study ID Numbers: |
CR109328 CNTO1959PSO3017 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | September 15, 2023 Key Record Dates |
| Last Update Posted: | April 24, 2024 |
| Last Verified: | April 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:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |