A Study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis

ISRCTN ISRCTN69978417
DOI https://doi.org/10.1186/ISRCTN69978417
EudraCT/CTIS number 2023-505121-14
IRAS number 1008235
ClinicalTrials.gov number NCT06143878
Secondary identifying numbers 77242113PSO3002, IRAS 1008235, CPMS 57592
Submission date
16/09/2023
Registration date
08/12/2023
Last edited
26/04/2024
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Plaque psoriasis is a skin disease that causes dry, itchy, thick, and raised skin patches on the skin.
Drugs that prevent interleukin (IL)-23* from binding to its receptor** may be an effective way to disease control. The study drug, JNJ-77242113, is a medicine designed to target the IL-23 receptor and block IL-23 from binding to it.
*A specific type of protein involved in inflammation.
**a protein that binds to a specific molecule
The purpose of this study is to see how effective JNJ-77242113 is compared to placebo (looks like JNJ-77242113 but it does not contain any active medication) and deucravacitinib in participants with moderate to severe plaque psoriasis.
Participants will receive JNJ-77242113, placebo, or deucravacitinib in 2:1:2 ratio which means in every 2 participants who receive JNJ-77242113, 1 will receive placebo, and 2 will receive deucravacitinib. Placebo will be administered in all treatment groups (JNJ-77242113, placebo or deucravacitinib) to maintain the blind until Week 24. This is a double-blind study, which means that the participant, caregiver, and the study doctor will not know whether the participants are receiving JNJ-77242113, placebo or deucravacitinib.

Who can participate?
Participants of 18 years or older with moderate to severe plaque psoriasis.

What does the study involve?
The study will be conducted in three periods:
1. Screening period (5 weeks)
2. Double-blind (156 weeks) treatment period: Participants will be randomly (like the flip of a coin) divided into 3 groups, JNJ-77242113, placebo, and deucravacitinib.
Group 1: JNJ-77242113 from Week 0 through Week 156.
Group 2: JNJ-77242113 matching placebo from Week 0 through Week 16, and thereafter JNJ-77242113 from Week 16 through Week 156.
Group 3: Deucravacitinib from Week 0 to Week 24 and thereafter JNJ-77242113 from Week 24 to Week 156.
Participants will undergo study assessments and tests, such as questionnaires, blood tests, vital signs, and physical exams. The possible side effects of the study drug will be recorded till end of the study. Blood samples will be taken at multiple timepoints to understand how the body responds to study drug.
3. Follow-up period (4 weeks): Participants will be monitored for their health after the last dose of study drug until the study ends.
All side effects will be recorded until the study ends. The total study duration is approximately 3 years and 2 months.

What are the possible benefits and risks of participating?
There is no established benefit to participants of this study. Based on scientific theory, taking JNJ-77242113 may reduce plaque psoriasis (red, scaly, itchy patches on the skin). However, this cannot be guaranteed because JNJ-77242113 is still under investigation as a treatment and it is not known whether JNJ-77242113 will work. If participants are put into the placebo treatment group, they will not receive JNJ-77242113 up to Week 16. Participants will start receiving JNJ-77242113 from Week 16 through Week 156 during this study.
Participants may experience some benefit from participation in the study that is not due to receiving JNJ-77242113, but due to regular visits and assessments monitoring overall health. Participation may help other people with plaque psoriasis in the future.
Participants may have side effects from the drugs or procedures used in this study that may be mild to severe and even life-threatening, and they can vary from person to person. Potential risks include hypersensitivity reactions, anti-drug antibody production, and infection. Skin biopsy (optional procedure) may cause mild bleeding, pain, discomfort, scarring, discoloration, and infection. Risks for deucravacitinib include hypersensitivity, infections including TB; malignancies; potential risks related to JAK inhibition (including major adverse cardiovascular events, deep vein thrombosis, and pulmonary embolism); rhabdomyolysis; laboratory abnormalities including elevations in creatine phosphokinase, triglycerides, liver enzymes, and decreased glomerular filtration rate; and advice to avoid use of live vaccines during deucravacitinib treatment.
The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks to participating in the study.
Not all possible side effects related to JNJ-77242113 are known at this moment. During the study, the sponsor may learn new information about JNJ-77242113. The study doctor will tell participants as soon as possible about any new information that might make them change their mind about being in the study, such as new risks.
To minimize the risk associated with taking part in the study, participants are frequently reviewed for any side effects and other medical events. Participants are educated to report any such events to the study doctor who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team.
There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study-related costs (e.g., travel/parking costs).

Where is the study run from?
Janssen-Cilag International N.V. (Netherlands)

When is the study starting and how long is it expected to run for?
September 2023 to June 2027

Who is funding the study?
Janssen-Cilag International N.V. (Netherlands)

Who is the main contact?
medinfo@its.jnj.com

Contact information

Dr Medical Information and Product Information Enquiry .
Scientific

50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom

+44 800 731 8450
medinfo@its.jnj.com
Dr Andrew Pink
Principal Investigator

Great Maze Pond
London
SE1 9RT
United Kingdom

Study information

Study designInterventional double-blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeSafety, Efficacy
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleA phase 3 multicentre, randomised, double-blind, placebo-controlled and deucravacitinib active comparator-controlled study to evaluate the efficacy and safety of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis - ICONIC-ADVANCE 1
Study acronymICONIC-ADVANCE 1
Study objectivesPrimary objective:
To evaluate the efficacy of JNJ-77242113 compared with placebo in participants with moderate to severe plaque psoriasis.

Secondary objectives:
1. To further evaluate efficacy (general and special area psoriasis) of JNJ-77242113 compared with placebo in participants with moderate to severe plaque psoriasis.
2. To evaluate effect of JNJ-77242113 compared with placebo on patient reported outcomes in participants with moderate to severe plaque psoriasis.
3. To evaluate effect and efficacy of JNJ-77242113 compared with deucravacitinib on clinician-reported outcomes and patient reported outcomes in participants with moderate to severe plaque psoriasis.
4. To evaluate the safety and tolerability of JNJ-77242113 compared with placebo and deucravacitinib in participants with moderately to severely plaque psoriasis.
5. To further evaluate the efficacy of JNJ-77242113 compared with placebo and deucravacitinib in participants with moderate to severe plaque psoriasis.
6. To further evaluate the efficacy (special area psoriasis) of JNJ-77242113 compared with placebo in participants with moderate to severe plaque psoriasis.
7. To further evaluate the effect of JNJ-77242113 compared with placebo on patient related outcomes in participants with moderately to severely plaque psoriasis.
8. To further evaluate the efficacy of JNJ-77242113 compared with deucravacitinib on patient related outcomes in participants with moderate to severe plaque psoriasis.
9. To evaluate the efficacy of JNJ-77242113 in participants with moderate to severe plaque psoriasis who switched from deucravacitinib to JNJ-77242113 treatment at Week 24.
Ethics approval(s)

Approved 25/10/2023, East Midlands - Leicester Central REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8284 ; leicestercentral.rec@hra.nhs.uk), ref: 23/EM/0227

Health condition(s) or problem(s) studiedPlaque psoriasis
InterventionThere are three treatment arms: JNJ-77242113 (experimental) arm, placebo comparator arm and active comparator (deucravacitinib) arm. Participants will be randomised via the online IWRS in a 2:1:2 ratio to one of these treatment arms. For the JNJ-77242113 (experimental) arm, participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24. For the placebo comparator arm, participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156. For the active comparator (deucravacitinib) arm, participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 through Week 156.
Intervention typeDrug
Pharmaceutical study type(s)Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, Therapy, Others (biomarkers)
PhasePhase III
Drug / device / biological / vaccine name(s)JNJ-77242113, deucravacitinib
Primary outcome measure1. Percentage of participants who achieve an IGA score of 0 or 1 and >=2-Grade improvement from baseline to 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).
2. Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) 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 measures1. JNJ-77242113 and Placebo Group: Percentage of participants achieving an IGA score of 0 at Week 16
2. JNJ-77242113 and Placebo Group: Percentage of participants achieving PASI 75 response from baseline at Weeks 4 and 16
3. JNJ-77242113 and Placebo Group: Percentage of participants achieving PASI 90 response at Week 8
4. JNJ-77242113 and Placebo Group: Percentage of participants achieving PASI 100 response at Week 16
5. JNJ-77242113 and Placebo Group: Percentage of participants achieving scalp-specific Investigator Global Assessment (ss-IGA) score of 0 or 1 and >=2 grade improvement from baseline at Week 16
6. JNJ-77242113 and Placebo Group: Percentage of participants achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16
7. JNJ-77242113 and Placebo Group: Percentage of participants achieving >=4-point improvement from baseline in PSSD Itch score at Weeks 4 and 16
8. JNJ-77242113 and Deucravacitinib Group: Percentage of participants achieving an IGA score of 0 or 1 and >=2 grade improvement from at Weeks 16 and 24
9. JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24
10. JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24
11. JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24
12. JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24
13. JNJ-77242113 and Deucravacitinib Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16
14. Number of participants with adverse events (AEs) and serious adverse events (SAEs) which occur from screening to Week 165.
15. Change from baseline in Body Surface Area (BSA) at Week 16
16. Change from baseline in PASI total score at Week 16
17. Percent improvement in PASI score from Baseline at Week 16
18. JNJ-77242113 and Placebo Group: Percentage of participants achieving a Static Physician’s Global Assessment of Genitalia (sPGA-G) score of 0 or 1 and at least a 2-grade improvement from baseline to Week 16
19. JNJ-77242113 and Placebo Group: Percentage of participants achieving a Physician’s Global Assessment of Hands and Feet (hf-PGA) score of 0 or 1 and at least a 2-grade improvement from baseline to Week 16
20. JNJ-77242113 and Placebo Group: Percent Change from baseline in Modified Nail Psoriasis Severity Index (mNAPSI) score at Week 16
21. JNJ-77242113 and Placebo Group: Percent of participants achieving Fingernail Physician’s Global Assessment (f-PGA) score of 0 or 1 at Week 16
22. JNJ-77242113 and Placebo Group: Change from baseline in PSSD Symptom score at Week 16
23. JNJ-77242113 and Placebo Group: Change from baseline in PSSD Sign score at Week 16
24. JNJ-77242113 and Placebo Group: Percentage of participants with PSSD Sign score of 0 at Week 16
25. JNJ-77242113 and Placebo Group: Percentage of participants achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 at Week 16
26. JNJ-77242113 and Placebo Group: Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16
27. JNJ-77242113 and Placebo Group: Change from baseline in total DLQI score at Week 16
28. JNJ-77242113 and Placebo Group: Change from baseline in domain scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) score at Week 16
29. JNJ-77242113 and Deucravacitinib Group: Percentage of participants achieving DLQI score of 0 or 1 at Weeks 16 and 24
30. JNJ-77242113 and Deucravacitinib Group: Percentage of participants achieving PSSD Symptom Score of 0 at Weeks 16 and 24
31. Percentage of participants who achieve PASI 75 response after Week 24 among PASI 75 non-responders to deucravacitinib at Week 24
32. Percentage of participants who achieve PASI 90 response after Week 24 among PASI 90 non-responders to deucravacitinib at Week 24
33. Percentage of participants achieving IGA score of 0 or 1 after Week 24, among participants with IGA score >=2 at Week 24 in the deucravacitinib group.
Overall study start date14/09/2023
Completion date01/06/2027

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants750
Key inclusion criteria1. Aged 18 years or older;
2. Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks before the first administration of study intervention
3. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline;
4. Total psoriasis area and severity index (PASI) >=12 at screening and baseline;
5. Total investigator global assessment (IGA) >=3 at screening and baseline;
6. Candidate for phototherapy or systemic treatment for plaque psoriasis.
Key exclusion criteria1. Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular);
2. Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium);
3. A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances;
4. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients;
5. Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study.
Date of first enrolment09/02/2024
Date of final enrolment19/04/2024

Locations

Countries of recruitment

  • Argentina
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Korea, South
  • Poland
  • Spain
  • Taiwan
  • United Kingdom
  • United States of America

Study participating centres

Salford Royal Hospital
Stott Lane
Eccles
Salford
M6 8HD
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom
Royal Berkshire Hospital
Craven Road
Reading
RG1 5AN
United Kingdom

Sponsor information

Janssen-Cilag International N.V.
Industry

Janssen Biologics BV - Clinical Registry Group - Archimedesweg 29
Leiden
2333 CM
Netherlands

ClinicalTrialsEU@its.jnj.com

Funders

Funder type

Industry

Janssen Research and Development
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Janssen R&D, Janssen Research & Development, Janssen Research & Development, LLC, Janssen Research & Development LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Research & Development at Janssen, JRD, J&J PRD
Location
United States of America

Results and Publications

Intention to publish date25/10/2028
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPeer reviewed scientific journals
Internal report
Conference presentation
Submission to regulatory authorities

The results of the study will be available to the wider scientific community via publication in scientific journals and presentation at scientific meetings. Study results will be available to participants via the provision of a Plain Language Summary at the end of the study and in addition, results will be published in the EudraCT database and in accordance with HRA requirements (lay summary of results in the final HRA Report).
IPD sharing planThe data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at yoda.yale.edu

Editorial Notes

26/04/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 21/08/2024 to 19/04/2024.
2. The overall study end date was changed from 25/10/2027 to 01/06/2027.
09/01/2024: Internal review.
18/09/2023: Trial's existence confirmed by NHS HRA.

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