A Long-Term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque Psoriasis
| ISRCTN | ISRCTN15135908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15135908 |
| EudraCT/CTIS number | 2021-004320-16 |
| IRAS number | 1005014 |
| ClinicalTrials.gov number | NCT05364554 |
| Secondary identifying numbers | IRAS 1005014, 77242113PSO2002, CPMS 52237 |
- Submission date
- 03/08/2022
- Registration date
- 11/10/2022
- Last edited
- 09/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Plaque psoriasis is a common, chronic, inflammatory condition, affecting about 3.5 million patients in the United States, European Union, and Japan. Despite advanced treatment options, large numbers of patients are not receiving these therapies. There is a need for safer options, fewer injections, and more effective oral medications. Janssen has an investigational drug called JNJ-77242113, which targets immune responses in the body and skin that impact diseases, such as psoriasis. It is hoped that targeting immune response processes may lead to less inflammation and a reduction in psoriasis disease activity.
This study is a follow-on trial of 77242113PSO2001 (https://www.isrctn.com/ISRCTN76915275), which is designed to evaluate long-term efficacy and safety of the investigational drug JNJ-77242113 in adults with moderate to severe plaque psoriasis.
Who can participate?
Patients who have completed the week 16 weeks in the study 77242113PSO2001 and who, in the opinion of the investigator, may benefit from inclusion in this long-term extension study.
What does the study involve?
This is a long-term extension study of JNJ-77242113 in eligible participants who completed the Week 16 visit of the originating 77242113PSO2001 study. All participants will receive active JNJ-77242113 study medication. The total study duration will be up to 40 weeks which will include:
1. A 36-week treatment period
2. A 4-week safety follow-up period after the last study intervention administration
Safety will be assessed by clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, and monitoring adverse events (AEs) throughout the study.
What are the possible benefits and risks of participating?
Possible benefits for patients taking JNJ-77242113 include improvements in plaque psoriasis symptoms based on current scientific theory. Only patients who may benefit from such drug treatment (i.e., with specific disease characteristics identified by study investigators) are eligible for study inclusion. Such patient participation may help other psoriasis patients in the future.
Study participants also may experience some benefits not due to receiving the study drug, but instead due to regular visits, assessments, and overall health monitoring. Long-term benefits, however, are not guaranteed to happen and there may not be any benefit to participants by being in this study.
Not all possible side effects and risks related to JNJ-77242113 are known, such that unexpected side effects may arise or be life-threatening.
A participant information sheet (which will be signed by every participant agreeing to participate in the study) includes a detailed section outlining all known risks/side effects to study participants.
To minimize any study-associated risks participants are frequently reviewed at every visit for side effects and adverse events and participants are educated to report any such problems to the study staff without delay.
Any serious adverse events that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team and the sponsor has implemented an Independent Data Review Committee.
Where is the study run from?
Janssen-Cilag International NV (Belgium) is the sponsor for this study. The study will be run at multiple healthcare locations both within the UK and around the world.
When is the study starting and how long is it expected to run for?
June 2022 to November 2023
Who is funding the study?
Janssen Research and Development, LLC (USA)
Who is the main contact?
Sarah Currie, JanssenUKRegistryQueries@its.jnj.com
Contact information
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 (0)800 731 8450 |
|---|---|
| medinfo@its.jnj.com |
Principal Investigator
Guy's Hospital
Great Maze Pond
London
London
United Kingdom
Study information
| Study design | Multicentre, long-term extension, double-blind, dose-ranging, parallel group, randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet provided |
| Scientific title | A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis. |
| Study acronym | FRONTIER 2 |
| Study objectives | Main objectives: 1. To evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis Secondary objectives: 1. To evaluate and assess additional long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis 2. To evaluate and assess the effect of JNJ-77242113 treatment on patient-reported psoriasis severity in participants with moderate-to-severe plaque psoriasis 3. To evaluate and assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis |
| Ethics approval(s) | Approved 03/08/2022, South Central - Berkshire B Research Ethics Committee (Meeting held by video-conference via Zoom; +44 (0)207 104 8253, +44 (0)207 104 8068, +44 (0)207 104 8276; berkshireb.rec@hra.nhs.uk), ref: 22/SC/0224 |
| Health condition(s) or problem(s) studied | Plaque psoriasis |
| Intervention | The total duration of this study is up to 40 weeks which includes a 36-week treatment period, and a 4-week safety follow-up period. Participants will continue to receive the dose randomly assigned by the online interactive web randomisation system tool from the preceding study (77242113PSO2001). Those participants assigned to the placebo treatment arm in the preceding study will be assigned to an active treatment arm in this study. Each active cohort group will also receive placebo to maintain blinding of dose regimens throughout the trial: 1. Group 1 will receive dose 1 of JNJ-77242113 once daily and placebo 2. Group 2 will receive dose 2 of JNJ-77242113 once daily and placebo 3. Group 3 will receive dose 3 of JNJ-77242113 once daily and placebo 4. Group 4 will receive dose 1 of JNJ-77242113 twice daily and placebo 5. Group 5 will receive dose 3 of JNJ-77242113 twice daily and placebo 6. Group 6 will receive dose 3 of JNJ-77242113 once daily and placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | JNJ-77242113 |
| Primary outcome measure | Percentage of participants achieving Psoriasis Area Severity Index (PASI) 75 score (≥75% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36. 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 | 1. Percentage of participants achieving PASI 90 score (≥90% improvement in PASI from baseline of the originating study [77242113PSO2001]) at week 36 2. Percentage of participants achieving PASI 100 score (≥100% improvement in PASI from baseline of the originating study [77242113PSO2001]) at week 36 3. Change from baseline of the originating study (77242113PSO2001) in PASI Total Score at Week 36 4. Percentage of participants achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) determined at Week 36. 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). 5. Change from baseline of originating study (77242113PSO2001) in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores reported at Week 36. The PSSD includes a 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. 6. Change from baseline of originating study (77242113PSO2001) in Psoriasis Symptoms and Signs Diary (PSSD) Signs Scores reported at Week 36 7. Percentage of participants achieving PSSD Symptoms Score of 0 at Week 36 among participants with a baseline (in the originating study 77242113PSO2001) symptoms score ≥1 8. Percentage of participants achieving PSSD Signs Score of 0 at Week 36 among participants with a baseline (in the originating study 77242113PSO2001) signs score ≥1 9. Number of participants with Adverse Events (AEs) monitored up to Week 40. 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. 10. Number of participants with Serious Adverse Events (SAEs) monitored up to Week 40. 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. |
| Overall study start date | 14/06/2022 |
| Completion date | 13/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 227 |
| Key inclusion criteria | 1. Must have completed the Week 16 visit in Protocol 77232114PSO2001 2. In the opinion of the investigator, may benefit from inclusion in this long-term extension (LTE) study 3. Must agree to avoid prolonged sun exposure and avoid the use of tanning booths or other ultraviolet light sources during the study 4. Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or Investigator’s global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention. 5. Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of the study intervention |
| Key exclusion criteria | 1. Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason 2. Has received any biologic therapy or experimental therapy since completion of the originating study 77242113PSO2001 3. Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention 4. Has received the bacille Clamette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention 5. Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (antiHCV) positive, or has another clinically active liver disease, or tests positive for HBsAg or anti-HCV |
| Date of first enrolment | 10/06/2022 |
| Date of final enrolment | 06/02/2023 |
Locations
Countries of recruitment
- Canada
- France
- Germany
- Japan
- Korea, South
- Poland
- Spain
- Taiwan
- United Kingdom
- United States of America
Study participating centres
Montreal
H2H2B5
Canada
Peterborough
K9J 5K2
Canada
Surrey
V3R 6A7
Canada
Mississauga
L4Y 4C5
Canada
Waterloo
N2J 1C4
Canada
Calgary
T2J 7E1
Canada
Windsor
N8W 1E6
Canada
Hamilton
L8N 1Y2
Canada
Dresden
1307
Germany
Hamburg
22391
Germany
Kiel
24105
Germany
Dresden
1097
Germany
Berlin
10783
Germany
Witten
58453
Germany
Munster
48149
Germany
Bochum
44793
Germany
Frankfurt am Main
60590
Germany
Heidelberg
69120
Germany
Mahlow
15831
Germany
Berlin
10789
Germany
Mainz
55131
Germany
Bad Bentheim
48455
Germany
Darmstadt
64283
Germany
Bonn
53127
Germany
Friedrichshafen
88045
Germany
Valencia
46026
Spain
Madrid
28041
Spain
Badalona
8916
Spain
Valencia
46940
Spain
Barakaldo
48903
Spain
Córdoba
14004
Spain
Bilbao
48013
Spain
Toulon
83800
France
Rouen
76031
France
Le Mans
72037
France
London
SE1 9RT
United Kingdom
Southampton
SO16 6YD
United Kingdom
Osaka Fu
593-8324
Japan
Sapporo
060-0063
Japan
Obihiro-shi
080-0013
Japan
Yokohama
221-0825
Japan
Shizuoka
420-8527
Japan
Takaoka
933-0871
Japan
Toyama
930-8550
Japan
Gyeonggi-do
13620
Korea, South
Seoul
5030
Korea, South
Busan
49241
Korea, South
Seoul
102-1703
Korea, South
Seoul
5505
Korea, South
Seoul
3080
Korea, South
Seoul
3722
Korea, South
Wroclaw
51-685
Poland
Osielsko
86031
Poland
Bialystok
15-351
Poland
Lodz
90-265
Poland
Warszawa
2962
Poland
Warszawa
02-953
Poland
Bialystok
15-888
Poland
Krakow
31-559
Poland
Taipei City
10048
Taiwan
Taoyuan
333
Taiwan
Tainan
704
Taiwan
Kaohsiung
83342
Taiwan
East Windsor
8520
United States of America
Rolling Meadows
60008
United States of America
Dallas
75231
United States of America
Ocala
34470
United States of America
Pittsburgh
15213
United States of America
Tampa
33613
United States of America
Plainfield
46168
United States of America
Portland
97210
United States of America
Houston
77004
United States of America
Webster
77598
United States of America
Fort Gratiot
48059
United States of America
Las Vegas
89119
United States of America
Sacramento
95815
United States of America
San Francisco
94132
United States of America
Spokane
99202
United States of America
Sponsor information
Industry
Janssen-Cilag International NV
Turnhoutseweg 30
Beerse
2340
Belgium
| Phone | No telephone contact available |
|---|---|
| prderacta@prdgb.jnj.com | |
| Website | https://www.janssen.com/belgium/ |
"ROR" |
https://ror.org/04yzcpd71 |
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 | 13/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. 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 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. 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 the Yale Open Data Access (YODA) Project site at yoda.yale.edu |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | Immunogenicity results have been redacted | 09/08/2024 | No | No |
Additional files
- ISRCTN15135908_REDACTED_CSR-Synopsis-77242113PSO2002-1357741_1363670.pdf
- Immunogenicity results have been redacted
Editorial Notes
09/08/2024: Redacted unpublished results uploaded. Total final enrolment added.
01/11/2022: Internal review.
03/08/2022: Trial’s existence confirmed by the HRA.
