A study of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis

ISRCTN	ISRCTN76915275
DOI	https://doi.org/10.1186/ISRCTN76915275
EudraCT/CTIS number	2021-003700-41
IRAS number	1004415
ClinicalTrials.gov number	NCT05223868
Secondary identifying numbers	77242113PSO2001, IRAS 1004415, CPMS 51021

Submission date: 03/02/2022
Registration date: 10/05/2022
Last edited: 04/10/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

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 several advanced treatment options, a large proportion of patients are not receiving these therapies and there is a need for safer options, fewer injections, and options for more effective oral medications. The investigational drug is called JNJ-77242113. It targets immune responses in the body and skin which impact diseases, such as psoriasis.
It is hoped that targeting this process may lead to less inflammation and a reduction in psoriasis disease activity. This study is designed to see if JNJ-77242113 is better than a placebo (dummy drug) in reducing psoriasis disease activity.

Who can participate?
Patients aged 18 years and over with moderate to severe plaque psoriasis.

What does the study involve?
This study will last for a maximum of 24 weeks and is divided into three parts:
1. Screening phase: 1 visit (up to 4 weeks)
2. Treatment phase: 7 visits (16 weeks)
3. Safety follow-up phase: 1 visit (4 weeks)
During study visits a variety of tests will be carried out including, but not limited to, blood pressure, heart activity, physical exam, questionnaires and blood samples. Patients will be randomly assigned to receive either oral JNJ-77242113 at one of five different dosing regimens or placebo twice a day during the treatment phase.

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 improve symptoms of plaque psoriasis. These benefits are not guaranteed to happen and there may not be any benefit to participants by being in this study. In addition, if participants are put into treatment Group 6 (placebo) they will not receive JNJ-77242113 and will only receive placebo during this study.
Participants may experience some benefit from participation in the study that is not due to receiving study drug, but due to regular visits and assessments monitoring overall health. Participation may help other people with psoriasis in the future.
Not all possible side effects and risks related to JNJ-77242113 are known and it is possible that unexpected side effects may arise or may be life-threatening. To minimise the risk associated with this, participants are frequently reviewed at every visit for side effects and adverse events. 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. The 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 participating in the study.

Where is the study run from?
Janssen-Cilag International NV 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?
January 2022 to February 2023

Who is funding the study?
Janssen Research & Development, LLC (Belgium)

Who is the main contact?
Sarah Currie (JanssenUKRegistryQueries@its.jnj.com)

Contact information

Dr Andrew Pink
Principal Investigator

Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

ORCID ID	0000-0001-5151-5539

Dr Medical Information and Product Information Enquiry
Scientific

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

Phone	+44 (0)800 731 8450 / 10494 567 444
Email	medinfo@its.jnj.com

Study information

Study design	Multicentre double-blind parallel-group randomized placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	A Phase IIb 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
Study acronym	FRONTIER 1
Study hypothesis	Main objectives: 1. To evaluate the dose-response of JNJ-77242113 at Week 16 in participants with moderate-to-severe plaque psoriasis Secondary objectives: 2. To characterize the additional efficacy of JNJ-77242113 versus placebo in participants with moderate-to-severe plaque psoriasis 3. To evaluate the effect of JNJ-77242113 treatment on patient-reported psoriasis severity versus placebo in participants with moderate-to-severe plaque psoriasis 4. To evaluate the effect of JNJ-77242113 treatment on dermatology-specific health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis 5. To evaluate the effect of JNJ-77242113 treatment on general health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis 6. To assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis
Ethics approval(s)	Approved 11/04/2022, London-Westminster Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8066, +44 (0)207 1048236; westminster.rec@hra.nhs.uk), ref: 22/LO/0125
Condition	Plaque psoriasis
Intervention	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. Participants will be randomly assigned to one of 6 treatment arms by an online interactive web randomisation system tool. Each active cohort group will also receive a placebo to maintain blinding of dose regimens throughout the trial: Group 1 will receive dose 1 of JNJ-77242113 once daily and placebo Group 2 will receive dose 2 of JNJ-77242113 once daily and placebo Group 3 will receive dose 3 of JNJ-77242113 once daily and placebo Group 4 will receive dose 1 of JNJ-77242113 twice daily and placebo Group 5 will receive dose 3 of JNJ-77242113 twice daily and placebo Group 6 will receive placebo twice daily
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 (greater than or equal to [≥] 75 percentage [%] improvement from baseline in PASI) determined at Week 16. 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. Change from baseline in PASI Total Score reported at Week 16. Change from baseline in PASI total score will be minored from baseline to week 16 and reported at Week 16 2. Percentage of participants achieving PASI 90 score (≥90% improvement from baseline in PASI) determined at Week 16 3. Percentage of participants achieving PASI 100 score (100% improvement from baseline in PASI) determined at Week 16 4. Percentage of participants achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) determined at Week 16. The IGA documents the investigator's assessment of the participant's 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. Percentage of participants achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) determined at Week 16 6. Change from baseline in Body Surface Area (BSA) reported at Week 16. Body Surface Area is a commonly used measure of severity of skin disease. It is defined as the percentage of the surface area of the body involved with the condition being assessed, (that is, plaque psoriasis) 7. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores reported at Week 16. 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. 8. Change from baseline in PSSD Signs Score reported at Week 16 9. Percentage of participants achieving PSSD Symptoms Score = 0 determined at Week 16 in participants with a baseline Symptoms Score ≥1 10. Percentage of participants achieving PSSD Sign Score = 0 determined at Week 16 in participants with a baseline Sign Score ≥1 11. Percentage of participants achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 determined at Week 16 in participants with baseline DLQI Score >1. 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 a greater impact on HRQoL. 12. Change from baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score reported at Week 16. 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. 13. Percentage of participants achieving ≥5-point improvement from baseline in PROMIS-29 Domain Score determined at Week 16 14. Number of participants with Adverse Events (AEs) monitored up to Week 24. 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 a clear causal relationship with the relevant investigational product 15. Number of participants with Serious Adverse Events (SAEs) monitored up to Week 24. 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	21/01/2022
Overall study end date	24/02/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	240
Participant inclusion criteria	1. 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 2. Participant is a candidate for phototherapy or systemic treatment for plaque psoriasis 3. Participant has a total body surface area (BSA) greater than or equal to (≥) 10 percent (%) at screening and baseline 4. Participant has a total Psoriasis area and severity index (PASI) ≥12 at screening and baseline 5. Participant has a total Investigator global assessment (IGA) ≥3 at screening and baseline
Participant exclusion criteria	1. Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) 2. 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) 3. 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) 4. 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 5. 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
Recruitment start date	24/01/2022
Recruitment end date	17/10/2022

Locations

Countries of recruitment

Canada
Czech Republic
England
France
Germany
Japan
Korea, South
Poland
Spain
Taiwan
United Kingdom
United States of America

Study participating centres

Castle Hill Hospital

Cottingham
HU16 5JQ
United Kingdom

Pinderfields Hospital

Aberford Road
Wakefield
WF1 4DG
United Kingdom

Russells Hall Hospital

Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Guy's and St Thomas' Hospitals

Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Southampton General Hospital

Tremona Road
Southampton
SO16 6YD
United Kingdom

Innovaderm Research

3530 Boulevard Saint-Laurent
Montreal
H2X 2V1
Canada

Skin Centre For Dermatology

775 Monaghan Road
Peterborough
K9J 5K2
Canada

Dr. Chih-Ho Hong Medical

15300 105 Avenue
Surrey
V3R 6A7
Canada

Dermedge Research

333 Lakeshore Road West
Mississauga
L4Y 4C5
Canada

K. Papp Clinical Research

135 Union Street East
Waterloo
N2J 1C4
Canada

Dermatology Research Institute Inc.

8500 Blackfoot Trail SE
Calgary
T2J 7E1
Canada

Xlr8 Medical Research

2425 Tecumseh Road East
Windsor
N8W 1E6
Canada

Dermatrials Research

25 Charlton Avenue East
Hamilton
L8N 1Y2
Canada

Fakultni Nemocnice Kralovske Vinohrady

Srobarova 50
Praha
775 20
Czech Republic

Fn Plzen Dermatovenerologicka Klinika (Main)

Edvarda Benese 13
Plzen
305 99
Czech Republic

Ccbr Klinicka Centra Czech, A.S.

Trida Miru 2800
Pardubice
53002
Czech Republic

Nemocnice Ceske Budejovice, A.S.

Bozeny Nemcove 54
Ceske Budejovice
37087
Czech Republic

Vseobecna Fakultní Nemocnice

U Nemocnice 2
Praha 2
128 08
Czech Republic

Dermamedica S.R.O.

Komenského 420
Nachod
547 01
Czech Republic

Clintrial S.R.O.

Pocernicka 1427/16
Praha
10 100 00
Czech Republic

Nemocnice Na Bulovce

Budínova 67/2
Praha 8
180 81
Czech Republic

Praglandia, S.R.O.

Ostrovskeho 253/3
Prague
15000
Czech Republic

Dermatologie Prof. Hercogove

Chlumcanskeho 497/5
Prague
180 81
Czech Republic

Ccr Prague S.R.O.

Vinohradska 1597/174
Praha
130 00
Czech Republic

Hia Sainte Anne

2 boulevard Sainte Anne
Toulon
83800
France

Hopital Charles Nicolle

1 rue de Germont
Rouen
76031
France

Hôpital Edouard Herriot

5 Pl D Arsonval
Lyon Cedex 03
69437
France

Centre Hospitalier Le Mans

194 Avenue Rubillard
Le Mans
72037
France

Chu Saint-Etienne

Avenue Albert Raimond
St Priest En Jarez
42270
France

Polyclinique De Courlancy

38bis Rue de Courlancy
Reims
51100
France

Chu De Grenoble - Hôpital Albert Michallon

Boulevard de la Chantourne
La Tronche
38700
France

Ich Hopital A. Morvan

2 Avenue Marechal Foch
Brest
29200
France

Universitatsklinikum Carl Gustav Carcus Dresden

Fetscherstr. 74
Dresden
01307
Germany

Mensingderma Research Gmbh

Heegbarg 4
Hamburg
22391
Germany

Universitatsklinikum Schleswig-Holstein - Kiel

Arnold-Heller-Str. 3, Haus 19
Kiel
24105
Germany

Praxis Für Dermatologie Und Venerologie

Hauptstrasse 36a
Dresden
01097
Germany

Rothhaar Studien Gmbh

Dermatologisches Studienzentrum
Berlin
10783
Germany

Hautarztpraxis

Annenstraße 151
Witten
58453
Germany

Charite - Universitatsmedizin Berlin (Ccm)

Charitéplatz 1
Berlin
10117
Germany

Uniklinik Münster -Klinik U. Pol. F. Hautkrankheiten

Von-Esmarch-Straße 58
Munster
48149
Germany

Niesmann & Othlinghaus Gbr

Alleestraße 80
Bochum
44793
Germany

Universitatsklinikum Frankfurt

Theodor-Stern-Kai 7
Frankfurt am Main
60590
Germany

Universitätsklinikum Heidelberg

Im Neuenheimer Feld 440
Heidelberg
69120
Germany

Dermatologische Gemeinschaftspraxis

Am Bahnhof 1
Mahlow
15831
Germany

Universitätsklinikum Leipzig Aör

Klinik f. Dermatologie
Leipzig
04103
Germany

Isa - Interdisciplinary Study Association Gmbh

Rankestrasse 34
Berlin
10789
Germany

Universitätsmedizin Der Johannes Gutenberg-Universität Mainz

Langenbeckstrasse 1
Mainz
55131
Germany

Fachklinik Bad Bentheim

Am Bade 1
Bad Bentheim
48455
Germany

Rosenpark Research Gmbh

Rheinstrasse 1
Darmstadt
64283
Germany

Universitatsklinikum Bonn

Klinik und Poliklinik für Dermatologie und Allergologie
Bonn
53127
Germany

Universitaetsklinikum Koeln

Kerpener Str. 62
Koeln
50937
Germany

Derma-Study-Center Friedrichshafen Gmbh

Charlottenstrasse 12/1
Friedrichshafen
88045
Germany

Seibo International Catholic Hospital

2-5-1 Nakaochiai, Shinjuku-ku
Tokyo
161-8521
Japan

Kume Clinic

1-65-2, Otorihigashimachi, Nishi Ku
Osaka Fu
593-8324
Japan

Miyata Dermatology Clinic

1147 Matsudo
Matsudo
271-0092
Japan

Sapporo Skin Clinic

2-1-1 Minami-3Jo Nishi
Sapporo
060-0063
Japan

Takagi Clinic

Nishi-sanjo Minami 4-16
Obihiro-shi
080-0013
Japan

Yamanashi Prefectural Central Hospital

1-1-1 Fujimi, Kofu-City, Yamanashi
Kofu
400-8506
Japan

Nomura Dermatology Clinic

4-27-14 tanmachi
Yokohama
221-0825
Japan

Meiwa Hospital

4-31, Agenaruo cho
Nishinomiya
663-8186
Japan

Charme Clinique

68-5, Akiyama
Matsudo-shi
270-2223
Japan

Shizuoka Prefectural General Hospital

4-27-1, Kitaando, Aoi-ku
Shizuoka
420-8527
Japan

Kumamoto Kenhoku Hospital

550, Tamana
Tamana
865-0005
Japan

Shirasaki Dermatology Clinic

3-5-33 Ekinan
Takaoka
933-0871
Japan

Toyama Prefectural Central Hospital

2-2-78 Nishinagae Toyama-shi
Toyama
930-8550
Japan

Mita Dermatology Clinic

4-5-8,Shiba
Minato
108-0014
Japan

Seoul National University Bundang Hospital

82, Gumi-ro,173 Beon-gil
Seongnam
463-707
Korea, South

Konkuk University Medical Center

120-1 NeunGdong-ro, Gwangjin-Gu
Seoul
05030
Korea, South

Pusan National University Hospital

179 Gudeok-Ro
Busan
49241
Korea, South

Kyunghee University Hospital

23 Kyungheedae-Ro
Seoul
102-1703
Korea, South

Asan Medical Center

88, Olympic-ro 43-gil, Songpa-gu
Seoul
05505
Korea, South

Seoul National University Hospital

101, Daehak-ro
Seoul
03080
Korea, South

Severance Hospital, Yonsei University Health System

50-1, Yonsei-ro, Seodaemun-gu
Seoul
03722
Korea, South

Wromedica

Mickiewicza 91
Wroclaw
51-685
Poland

Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski S.C.

Tuberozy 3
Osielsko
86031
Poland

Nzoz Zdrowie Osteo-Medic

ul. Wiejska 81
Bialystok
15-351
Poland

Dermed Centrum Medyczne Sp. Z O.O

ul. Piotrkowska 48
Lodz
90-265
Poland

Royalderm Agnieszka Nawrocka

K.Kieślowskiego 3B/3
Warszawa
02962
Poland

Klinika Ambroziak Estederm Sp. Z O.O

Kosiarzy 9A
Warsaw
02-953
Poland

Nzoz Specderm

Kardynala Stefana Wyszynskiego 10 lokal 11
Bialystok
15-888
Poland

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Stefana Rogozinskiego 6/U3
Krakow
31-559
Poland

Hosp. Univ. I Politecni La Fe

Avda. Fernando Abril Martorell 106, Torre C, Planta 7
Valencia
46026
Spain

Hosp. Univ. 12 De Octubre

Avda. Cordoba sn
Madrid
28041
Spain

Hosp. Univ. Germans Trias I Pujol

Ctra. De Canyet s/n
Barcelona
08916
Spain

Hosp. De Manises

Av. De la Generalitat Valenciana 50
Valencia
46940
Spain

Hosp. Provincial De Pontevedra

C/ Simón Bolivar s/n
Pontevedra
36001
Spain

Hosp. Univ. De Cruces

Plaza de Cruces, S/N
Barakaldo
48902
Spain

Hosp. Reina Sofia

C/ Menéndez Pidal s/n
Córdoba
14004
Spain

Hosp. Univ. De Basurto

Avenida de Montevideo, 18
Bilbao
48013
Spain

National Taiwan University Hospital

Dermatology Department
Taipei City
10048
Taiwan

Chang-Gung Memorial Hospital, Linkou Branch

No.5 Fuxing street
Taoyuan
333
Taiwan

National Cheng Kung University Hospital

138 Sheng-Li Road
Tainan
70403
Taiwan

Chang Gung Memorial Hospital

Kaohsiung Branch
Kaohsiung
83342
Taiwan

Windsor Dermatology, Pc

59 One Mile Rd Ext Ste G
East Windsor
08520
United States of America

Oregon Medical Research Center

9495 SW Locust Street
Portland
97223
United States of America

Arlington Dermatology

5301 Keystone Ct.
Rolling Meadows
60008
United States of America

Modern Research Associates

9101 N. Central Expressway
Dallas
75231
United States of America

Renstar Medical Research

21 NE 1st Ave
Ocala
34470
United States of America

Dawes Fretzin Clinical Research Group, Llc

7910 N Shadeland Ave
Indianapolis
46250
United States of America

University Of Pittsburgh

Department Of Dermatology
3601 5th Ave
Pittsburgh
15213
United States of America

Forcare Clinical Research, Inc.

15416 North Florida Avenue
Tampa
33613
United States of America

Clinical Partners

1524 Atwood Avenue
Johnston
02919
United States of America

Indiana Clinical Trial Center

824 Edwards Drive
Plainfield
46168
United States of America

Alliance Dermatology And Mohs Center, P.C.

4045 E Bell Rd
Phoenix
85032
United States of America

Austin Institute For Clinical Research

1601 E Pflugerville Pkwy
Pflugerville
78660
United States of America

Dermassociates, Pc

15245 Shady Grove Road
Rockville
20850
United States of America

Virginia Clinical Research

6160 Kempville Road
Norfolk
23502
United States of America

Oregon Dermatology And Research Center

2565 NW Lovejoy
Portland
97210
United States of America

Center For Clinical Studies

1401 Binz Street
Houston
77004
United States of America

University Of Utah

243 East 6100 South
Murray
84107
United States of America

The South Bend Clinic Center For Research

211 N Eddy St
South Bend
46617-2808
United States of America

Alpha Dermatology Of Pa, Llc

670 Lawn Ave
Sellersville
18960
United States of America

Ccd Research, Pllc

1 Willowbrook Road
Cromwell
06416
United States of America

Center For Clinical Studies

451 North Texas Avenue
Webster
77598
United States of America

Hamzavi Dermatology

2950 Keewahdin Road
Fort Gratiot
48059
United States of America

Vivida Dermatology

2110 East Flamingo Road, Suite 213
Las Vegas
89119
United States of America

Pacific Skin Institute

1495 River Park Drive
Sacramento
95815
United States of America

Synergy Clinical Research

595 Buckingham Way
San Francisco
94132
United States of America

Atlanta Dermatology, Vein & Research Center

11800 Atlantis Place
Alpharetta
30022
United States of America

Dermatology Associates

1730 Minor Avenue
Seattle
98101
United States of America

Medical Dermatology Specialists

1331 N. 7th Street
Phoenix
85006
United States of America

Premier Clinical Research

324 South Sherman
Spokane
99202
United States of America

Olympian Clinical Research

1201 S Myrtle Ave
Clearwater
33756
United States of America

Oakview Dermatology

2111 East State Street
Athens
45701
United States of America

Sponsor information

Janssen (Belgium)
Industry

Turnhoutseweg 30
Beerse
2340
Belgium

Email	prderacta@prdgb.jnj.com
Website	https://www.janssen.com/netherlands/
"ROR"	https://ror.org/04yzcpd71

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 date	31/10/2024
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 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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Other unpublished results			04/10/2024	No	No

Additional files

ISRCTN76915275 77242113PSO2001_CSR Synopsis_English.pdf

Editorial Notes

04/10/2024: A file of unpublished results was added.
07/06/2022: Internal review.
08/04/2022: ISRCTN received notification of combined HRA/MHRA approval for this trial on 08/04/2022.
03/02/2022: Trial's existence confirmed by the HRA.