A study of JNJ-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis
| ISRCTN | ISRCTN21453767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21453767 |
| EudraCT/CTIS number | 2023-505120-59 |
| IRAS number | 1008234 |
| ClinicalTrials.gov number | NCT06095115 |
| Secondary identifying numbers | 77242113PSO3001, IRAS 1008234, CPMS 57536 |
- Submission date
- 24/08/2023
- Registration date
- 08/11/2023
- Last edited
- 26/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Plaque psoriasis is a skin disease that causes red, scaly, and sometimes painful and itchy 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 specific molecule.
The purpose of this study is to check the efficacy of JNJ-77242113 compared to placebo (looks like JNJ-77242113 but it does not contain any active medication) in participants with moderate to severe plaque psoriasis.
Who can participate?
Study includes participants 12 years or older with moderate to severe plaque psoriasis (in the UK, only participants 18 years or older will be recruited).
What does the study involve?
The study will be conducted in 3 periods:
1. Screening period (5 weeks): Participants will be screened to confirm if they can take part in the study.
2. Double-blind (156 weeks) treatment period: Both Adult and Adolescent participants will be divided into 2 arms to receive either JNJ-77242113 or placebo.
Adult:
Group 1: Participants will receive JNJ-77242113 orally from Weeks 0 through Week 24. At Week 24, psoriasis area and severity index (PASI) 75 responders or participants who achieve an investigator global assessment (IGA) score of 0 or 1 and have >=2-grade improvement from baseline will be re-randomized either to continue JNJ-77242113 orally or to placebo whereas PASI 75 and IGA 0 to 1 non-responders will continue to receive JNJ-77242113 through Week 52. Participants randomized to placebo will be retreated prior to Week 52 if they lose >=50% of their PASI score at Week 24. From Weeks 52 to 156, all participants will receive JNJ-77242113.
Group 2: Participants will receive JNJ-77242113 matching placebo from Weeks 0 to 16 and thereafter, JNJ-77242113 from Weeks 16 through 156.
Adolescent:
Group 1: Participants will receive JNJ-77242113 orally from Weeks 0 through 156
Group 2: Participants will receive JNJ-77242113 matching placebo from Weeks 0 to 16 and thereafter JNJ-77242113 from Weeks 16 through 156.
Participants will undergo study assessments and tests, such as questionnaire, blood tests, vital signs, and physical exams. The possible side effects of the study drug will be recorded till end of the study.
3. Follow-up period (4 weeks): Participants blood samples will be taken at multiple timepoints to understand how the body responds to study drug. will be monitored for their health after the last dose of study drug until the study ends.
All side effects will be recorded until 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. Some potential risks included hypersensitivity reactions, anti-drug antibody production, and infection. Skin biopsy (optional procedure) may cause mild bleeding, pain, discomfort, scarring, discoloration, and infection.
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. For participants under the legal age of consent, parent (s) (preferably both if available or as per local requirement) or guardian will sign a separate inform consent form.
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 minimise 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 NV (Netherlands)
When is the study starting and how long is it expected to run for?
August 2023 to April 2027
Who is funding the study?
Janssen Research and Development LLC (USA)
Who is the main contact?
medinfo@its.jnj.com
Contact information
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 800 731 8450 |
|---|---|
| medinfo@its.jnj.com |
Principal Investigator
Stott Lane
Salford
M6 8HD
United Kingdom
Study information
| Study design | Interventional double-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | A phase 3 multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis with randomised withdrawal and retreatment ICONIC-LEAD |
| Study acronym | ICONIC-LEAD |
| Study objectives | Primary objective: To assess the efficacy of JNJ-77242113 in participants with moderate to severe plaque psoriasis. Secondary objectives: 1. To further evaluate efficacy (general and special area psoriasis) of JNJ-77242113 in participants with moderate to severe plaque psoriasis. 2. To evaluate the effect of JNJ-77242113 on patient reported outcomes (PROs) in participants with moderate to severe plaque psoriasis. 3. To evaluate the maintenance of efficacy of JNJ-77242113 compared with treatment withdrawal during the randomised withdrawal period. 4. To assess the safety and tolerability of JNJ-77242113 in participants with moderate to severe plaque psoriasis. 5. To evaluate long-term psoriasis efficacy of JNJ-77242113 in adolescent participants with moderate to severe plaque psoriasis |
| Ethics approval(s) |
Approved 03/11/2023, London - Dulwich REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 115 8839435; dulwich.rec@hra.nhs.uk), ref: 23/LO/0790 |
| Health condition(s) or problem(s) studied | Plaque psoriasis |
| Intervention | The study will be conducted in 3 periods: 1. Screening period (5 weeks): Participants will be screened to confirm if they can take part in the study. 2. Double-blind (156 weeks) treatment period: Both Adult and Adolescent participants will be divided into 2 arms to receive either JNJ-77242113 or placebo. Adult: Group 1: Participants will receive JNJ-77242113 orally from Weeks 0 through Week 24. At Week 24, psoriasis area and severity index (PASI) 75 responders or participants who achieve an investigator global assessment (IGA) score of 0 or 1 and have >=2-grade improvement from baseline will be re-randomized either to continue JNJ-77242113 orally or to placebo whereas PASI 75 and IGA 0 to 1 non-responders will continue to receive JNJ-77242113 through Week 52. Participants randomized to placebo will be retreated prior to Week 52 if they lose >=50% of their PASI score at Week 24. From Weeks 52 to 156, all participants will receive JNJ-77242113. Group 2: Participants will receive JNJ-77242113 matching placebo from Weeks 0 to 16 and thereafter, JNJ-77242113 from Weeks 16 through 156. Adolescent: Group 1: Participants will receive JNJ-77242113 orally from Weeks 0 through 156 Group 2: Participants will receive JNJ-77242113 matching placebo from Weeks 0 to 16 and thereafter JNJ-77242113 from Weeks 16 through 156. Participants will undergo study assessments and tests, such as questionnaire, blood tests, vital signs, and physical exams. The possible side effects of the study drug will be recorded till end of the study. 3. Follow-up period (4 weeks) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, Therapy |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | JNJ-77242113 |
| Primary outcome measure | 1. Percentage of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 and greater than or equal to (>=)2-grade improvement from baseline to Week 16 2. Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90 response at Week 16. |
| Secondary outcome measures | 1. Percentage of participants achieving an IGA score of 0 at Week 16 2. Percentage of participants achieving PASI 75 response at Weeks 4 and 16 3. Percentage of participants achieving PASI 90 response at Week 8 4. Percentage of participants achieving PASI 100 response at Week 16 5. Percentage of participants achieving scalp-specific Investigator Global Assessment (ss-IGA) score of 0 or 1 and >=2 grade improvement baseline to Week 16 6. Percentage of participants achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 7. Percentage of participants achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 4 and 16 8. Percentage of participants achieving >=4-point improvement from baseline in PSSD Itch score to Weeks 4 and 16 9. Time to loss of PASI 75 10. Time to loss of PASI 90 11. Number of participants with treatment-emergent adverse events (AEs) 12. Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) 13. Change from baseline in Body Surface Area (BSA) at Week 16 14. Change from baseline in PASI total score to Week 16 15. Percent improvement in PASI score from baseline to Week 16 16. 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 in genital psoriasis from baseline to Week 16 17. 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 at Week 16 18. Percent change from baseline in modified Nail Psoriasis Severity Index (mNAPSI) score at Week 16 19. Percent of participants achieving Fingernail Physician’s Global Assessment (f-PGA) score of 0 or 1 from baseline to Week 16 20. Change from baseline in PSSD Symptom score to Week 16 21. Change from baseline in PSSD Sign score to Week 16 22. Percentage of participants achieving PSSD sign score of 0 at Week 16 23. Percentage of participants achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 at Week 16 24. Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 25. Change from baseline in total DLQI Score at Week 16 26. Change from baseline in domain scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) score at Week 16 27. Percentage of participants achieving Children’s Dermatology Life Quality Index (CDLQI) score of 0 or 1 at Week 16. 28. Change from baseline in CDLQI at Week 16. 29. Change from baseline in the domain scores of the PROMIS-25 Paediatric score at Week 16. 30. Percentage of participants achieving IGA score of 0 at Week 52 31. Percentage of participants achieving PASI 100 response at Week 52 32. Time to loss of IGA 0 to 1 response 33. Percentage of Adolescent Participants Achieving IGA Score of 0 or 1 and >=2 Improvement From Baseline to Week 52 34. Percentage of Adolescent Participants Achieving PASI 75 Response at Week 52 35. Percentage of Adolescent Participants Achieving PASI 90 Response at Week 52 |
| Overall study start date | 22/08/2023 |
| Completion date | 06/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 684 |
| Key inclusion criteria | 1. Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention 2. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline 3. Total psoriasis area and severity index (PASI) >=12 at screening and baseline 4. Total investigator global assessment (IGA) >=3 at screening and baseline 5. Candidate for phototherapy or systemic treatment for plaque psoriasis 6. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention |
| Key exclusion criteria | 1. Non-plaque 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 procedures, (for example, requiring general anaesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study. |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- Argentina
- Australia
- Canada
- China
- France
- Germany
- Hungary
- Italy
- Japan
- Korea, South
- Poland
- Spain
- Taiwan
- Türkiye
- United Kingdom
- United States of America
Study participating centres
London
SE1 9RT
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Leeds
LS7 4SA
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Reading
RG1 5AN
United Kingdom
Sponsor information
Industry
Clinical Registry Group - Archimedesweg 29
Leiden
2333 CM
Netherlands
| ClinicalTrialsEU@its.jnj.com |
Funders
Funder type
Industry
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 date | 10/07/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer-reviewed scientific journals Internal report Conference presentation Submission to regulatory authorities 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 provision of a Plain Language Summary at the end of the study and in addition results will be published in the EudraCT database. |
| IPD sharing plan | The 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 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. Total final enrolment added.
2. The recruitment end date was changed from 28/05/2024 to 01/03/2024.
3. The overall study end date was changed from 14/06/2027 to 06/04/2027.
11/12/2023: The ethics approval was added.
01/12/2023: Internal review.
24/08/2023: Trial's existence confirmed by NHS HRA.
