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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05242471




Registration number
NCT05242471
Ethics application status
Date submitted
15/02/2022
Date registered
16/02/2022

Titles & IDs
Public title
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Scientific title
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2021-003314-39
Secondary ID [2] 0 0
CR109178
Universal Trial Number (UTN)
Trial acronym
DUET-CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Guselkumab
Treatment: Other - Golimumab
Treatment: Other - JNJ-78934804
Treatment: Drugs - Placebo

Placebo comparator: Group 1: Placebo - Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Experimental: Group 2: Guselkumab - Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Experimental: Group 3: Golimumab - Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Experimental: Group 4: JNJ-78934804 (High-dose) - Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Experimental: Group 5: JNJ-78934804 (Mid-dose) - Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Experimental: Group 6: JNJ-78934804 (Low-dose) - Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.


Treatment: Other: Guselkumab
Guselkumab will be administered as subcutaneous injection.

Treatment: Other: Golimumab
Golimumab will be administered as subcutaneous injection.

Treatment: Other: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.

Treatment: Drugs: Placebo
Placebo will be administered as subcutaneous injection.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Clinical Remission at Week 48
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Percentage of Participants with Endoscopic Response at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants with Endoscopic Remission at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48
Timepoint [3] 0 0
Week 48
Secondary outcome [4] 0 0
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48
Timepoint [5] 0 0
Week 48
Secondary outcome [6] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [6] 0 0
Up to Week 48
Secondary outcome [7] 0 0
Percentage of Participants with Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to Week 48
Secondary outcome [8] 0 0
Clinical Laboratory Parameters Over Time
Timepoint [8] 0 0
Up to Week 48
Secondary outcome [9] 0 0
Vital Sign Parameters Over Time
Timepoint [9] 0 0
Up to Week 48
Secondary outcome [10] 0 0
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
Timepoint [10] 0 0
Up to Week 48
Secondary outcome [11] 0 0
Serum Concentrations of Guselkumab Over Time
Timepoint [11] 0 0
Up to Week 48
Secondary outcome [12] 0 0
Serum Concentrations of Golimumab Over Time
Timepoint [12] 0 0
Up to Week 48
Secondary outcome [13] 0 0
Percentage of Participants with Antibodies to Guselkumab
Timepoint [13] 0 0
Up to Week 48
Secondary outcome [14] 0 0
Titers of Antibodies to Guselkumab
Timepoint [14] 0 0
Up to Week 48
Secondary outcome [15] 0 0
Percentage of Participants with Antibodies to Golimumab
Timepoint [15] 0 0
Up to Week 48
Secondary outcome [16] 0 0
Titers of Antibodies to Golimumab
Timepoint [16] 0 0
Up to Week 48
Secondary outcome [17] 0 0
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Timepoint [17] 0 0
Up to Week 48
Secondary outcome [18] 0 0
Percentage of Participants with Neutralizing Antibodies to Golimumab
Timepoint [18] 0 0
Up to Week 48

Eligibility
Key inclusion criteria
* Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
* Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
* Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
* If female and of childbearing potential, must meet the contraception and reproduction requirements
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Complications of CD that may be anticipated to require surgery
* Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
* Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
* Has a draining (example, functioning) stoma or ostomy
* Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/11/2029
Actual
Sample size
Target
Accrual to date
Final
703
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Western Health - Footscray
Recruitment hospital [5] 0 0
St Vincent's hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Prince Alfred Hospital - Newtown
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Royal Adelaide Hospital - North Terrace
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
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Nepean Hospital - Penrith
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Mater Hospital Brisbane Inflammatory Bowel Diseases - South Brisbane
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5011 - Adelaide
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3128 - Box Hill
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3168 - Clayton
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3011 - Footscray
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3002 - Melbourne
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2042 - Newtown
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5000 - North Terrace
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3050 - Parkville
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2747 - Penrith
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4101 - South Brisbane
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Roma
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Italy
State/province [189] 0 0
Rozzano
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Italy
State/province [190] 0 0
Torino
Country [191] 0 0
Japan
State/province [191] 0 0
Asahikawa
Country [192] 0 0
Japan
State/province [192] 0 0
Bunkyo Ku
Country [193] 0 0
Japan
State/province [193] 0 0
Chikushino
Country [194] 0 0
Japan
State/province [194] 0 0
Fukuoka-shi
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Japan
State/province [195] 0 0
Hachioji
Country [196] 0 0
Japan
State/province [196] 0 0
Hamamatsu
Country [197] 0 0
Japan
State/province [197] 0 0
Hirosaki
Country [198] 0 0
Japan
State/province [198] 0 0
Hitachi
Country [199] 0 0
Japan
State/province [199] 0 0
Hukuoka
Country [200] 0 0
Japan
State/province [200] 0 0
Hyogo
Country [201] 0 0
Japan
State/province [201] 0 0
Kagoshima
Country [202] 0 0
Japan
State/province [202] 0 0
Kamakura
Country [203] 0 0
Japan
State/province [203] 0 0
Kanazawa
Country [204] 0 0
Japan
State/province [204] 0 0
Kashiwa
Country [205] 0 0
Japan
State/province [205] 0 0
Kawagoe
Country [206] 0 0
Japan
State/province [206] 0 0
Kitakyushu
Country [207] 0 0
Japan
State/province [207] 0 0
Kobe
Country [208] 0 0
Japan
State/province [208] 0 0
Kumamoto
Country [209] 0 0
Japan
State/province [209] 0 0
Kurume
Country [210] 0 0
Japan
State/province [210] 0 0
Kyoto
Country [211] 0 0
Japan
State/province [211] 0 0
Mitaka
Country [212] 0 0
Japan
State/province [212] 0 0
Morioka
Country [213] 0 0
Japan
State/province [213] 0 0
Nagaoka
Country [214] 0 0
Japan
State/province [214] 0 0
Nagasaki
Country [215] 0 0
Japan
State/province [215] 0 0
Nagoya
Country [216] 0 0
Japan
State/province [216] 0 0
Niigata
Country [217] 0 0
Japan
State/province [217] 0 0
Okayama-shi
Country [218] 0 0
Japan
State/province [218] 0 0
Osaka
Country [219] 0 0
Japan
State/province [219] 0 0
Otsu
Country [220] 0 0
Japan
State/province [220] 0 0
Saga-shi
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Japan
State/province [221] 0 0
Saitama
Country [222] 0 0
Japan
State/province [222] 0 0
Sakura
Country [223] 0 0
Japan
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Sapporo
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Japan
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Sendai
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Japan
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Shimotsuga-gun
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Japan
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Shimotsuke
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Japan
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Japan
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Sumida ku
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Japan
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Japan
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Japan
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Japan
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Toyota
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Japan
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Japan
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Jordan
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Suwon-si
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Korea, Republic of
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Suwon
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Alor Setar
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Ampang
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George Town
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Dordrecht
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State/province [252] 0 0
Leiden
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Netherlands
State/province [253] 0 0
Maastricht
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State/province [254] 0 0
Rotterdam
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Wellington
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Alesund
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State/province [260] 0 0
Gjettum
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Norway
State/province [261] 0 0
Lørenskog
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Norway
State/province [262] 0 0
Oslo
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State/province [263] 0 0
Tromso
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Bydgoszcz
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
State/province [268] 0 0
Olsztyn
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Poland
State/province [269] 0 0
Poznan
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Poland
State/province [270] 0 0
Rzeszow
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Poland
State/province [271] 0 0
Sopot
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Poland
State/province [272] 0 0
Szczecin
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Poland
State/province [273] 0 0
Torun
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Poland
State/province [274] 0 0
Warszawa
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Poland
State/province [275] 0 0
Wloclawek
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Poland
State/province [276] 0 0
Wroclaw
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Poland
State/province [277] 0 0
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Portugal
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Lisboa
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Portugal
State/province [279] 0 0
Portimao
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Portugal
State/province [280] 0 0
Porto
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Portugal
State/province [281] 0 0
Santa Maria da Feira
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Singapore
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Singapore
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Celje
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Ljubljana
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South Africa
State/province [285] 0 0
Benoni
Country [286] 0 0
South Africa
State/province [286] 0 0
Cape Town
Country [287] 0 0
South Africa
State/province [287] 0 0
Durban
Country [288] 0 0
Spain
State/province [288] 0 0
Madrid
Country [289] 0 0
Spain
State/province [289] 0 0
Pamplona
Country [290] 0 0
Spain
State/province [290] 0 0
Pontevedra
Country [291] 0 0
Spain
State/province [291] 0 0
Sabadell
Country [292] 0 0
Spain
State/province [292] 0 0
Santander
Country [293] 0 0
Spain
State/province [293] 0 0
Torrejón de Ardoz
Country [294] 0 0
Sweden
State/province [294] 0 0
Orebro
Country [295] 0 0
Sweden
State/province [295] 0 0
Solna
Country [296] 0 0
Sweden
State/province [296] 0 0
Stockholm
Country [297] 0 0
Switzerland
State/province [297] 0 0
Basel
Country [298] 0 0
Switzerland
State/province [298] 0 0
Bern
Country [299] 0 0
Switzerland
State/province [299] 0 0
St. Gallen
Country [300] 0 0
Switzerland
State/province [300] 0 0
Zuerich
Country [301] 0 0
Taiwan
State/province [301] 0 0
Changhua
Country [302] 0 0
Taiwan
State/province [302] 0 0
Taichung
Country [303] 0 0
Taiwan
State/province [303] 0 0
Tainan
Country [304] 0 0
Taiwan
State/province [304] 0 0
Taipei
Country [305] 0 0
United Kingdom
State/province [305] 0 0
Belfast
Country [306] 0 0
United Kingdom
State/province [306] 0 0
Birmingham
Country [307] 0 0
United Kingdom
State/province [307] 0 0
Cambridge
Country [308] 0 0
United Kingdom
State/province [308] 0 0
Glasgow
Country [309] 0 0
United Kingdom
State/province [309] 0 0
High Wycombe
Country [310] 0 0
United Kingdom
State/province [310] 0 0
London
Country [311] 0 0
United Kingdom
State/province [311] 0 0
Oxford
Country [312] 0 0
United Kingdom
State/province [312] 0 0
Wolverhampton.

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05242471