DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05242471

Collaborator

(none)

715

Enrollment

168

Locations

Arms

24.5

Anticipated Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Biological: Guselkumab Biological: Golimumab Biological: JNJ-78934804 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

715 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Jul 29, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Placebo Placebo will be administered as subcutaneous injection.
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.	Biological: Guselkumab Guselkumab will be administered as subcutaneous injection.
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.	Biological: Golimumab Golimumab will be administered as subcutaneous injection.
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.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
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.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
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.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Clinical Remission at Week 48 [Week 48]
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 48 [Week 48]
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).

Secondary Outcome Measures

Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48 [Week 48]
Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.
Percentage of Participants with Endoscopic Remission at Week 48 [Week 48]
Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD.
Percentage of Participants with Clinical Remission at Week 24 [Week 24]
Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 24 [Week 24]
Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Percentage of Participants with Adverse Events (AEs) [Up to Week 48]
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Percentage of Participants with Serious Adverse Events (SAEs) [Up to Week 48]
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Serum Concentrations of Guselkumab Over Time [Up to Week 48]
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
Serum Concentrations of Golimumab Over Time [Up to Week 48]
Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
Percentage of Participants with Antibodies to Guselkumab [Up to Week 48]
Percentage of participants with antibodies to guselkumab will be reported.
Titers of Antibodies to Guselkumab [Up to Week 48]
Titers of antibodies to guselkumab will be reported.
Percentage of Participants with Antibodies to Golimumab [Up to Week 48]
Percentage of participants with antibodies to golimumab will be reported.
Titers of Antibodies to Golimumab [Up to Week 48]
Titers of antibodies to golimumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Guselkumab. [Up to Week 48]
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Golimumab [Up to Week 48]
Percentage of participants with neutralizing antibodies to golimumab will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Liver Center	Birmingham	Alabama	United States	35233
2	Valley Gastroenterology Medical Group	Arcadia	California	United States	91006
3	Southern California Research Center	Coronado	California	United States	92118
4	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
5	UCI Irvine Medical Center	Orange	California	United States	92868
6	Medical Associates Research Group, Inc.	San Diego	California	United States	92123
7	University of Colorado	Aurora	Colorado	United States	80045
8	Medical Research Center of Connecticut	Hamden	Connecticut	United States	06518
9	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
10	Gastrointestinal Specialists of Georgia	Marietta	Georgia	United States	30060
11	Ascension via Christi Research	Wichita	Kansas	United States	67208
12	Univ. of KS School of Med	Wichita	Kansas	United States	67214-3124
13	University of Kentucky	Lexington	Kentucky	United States	40536
14	Gastroenterology Clinic of Acadiana	Lafayette	Louisiana	United States	70503
15	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
16	University of Maryland	Baltimore	Maryland	United States	21201
17	Institute for Digestive Health and Liver Disease	Baltimore	Maryland	United States	21202-2102
18	Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
19	Brigham & Women's Hospital	Chestnut Hill	Massachusetts	United States	02467
20	Detroit Clinical Research Center	Livonia	Michigan	United States	48152
21	Care Access Las Vegas	Las Vegas	Nevada	United States	89148
22	Rutgers University	New Brunswick	New Jersey	United States	08901
23	Lenox Hill Hospital	New York	New York	United States	10075
24	Tryon Medical Group	Charlotte	North Carolina	United States	28210
25	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
26	Cleveland Clinic	Cleveland	Ohio	United States	44195-6501
27	ClinOhio Research Services	Columbus	Ohio	United States	43235
28	Susquehanna Gastroenterology Associates	Harrisburg	Pennsylvania	United States	17110-3673
29	University Gastroenterology	Providence	Rhode Island	United States	02905
30	Digestive Disease Associates	Rock Hill	South Carolina	United States	29732
31	Saint Francis Hospital	Germantown	Tennessee	United States	38138
32	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37067
33	Amel Med LLC. Research	Austin	Texas	United States	78750
34	Gastroenterology Clinic Of San Antonio P A	San Antonio	Texas	United States	78229
35	Advanced Research Institute	Ogden	Utah	United States	84405
36	University of Virginia	Charlottesville	Virginia	United States	22908
37	Hunter Holmes McGuire Veterans Affairs Medical Center	Richmond	Virginia	United States	23249
38	Washington Gastroenterology, PLLC	Bellevue	Washington	United States	98004
39	Swedish Medical Center	Seattle	Washington	United States	98104
40	University of Washington	Seattle	Washington	United States	98195
41	Inmunología BA	Ciudad Autonoma de Buenos Aires		Argentina	C1059
42	CIPREC	Ciudad Autonoma de Buenos Aires		Argentina	C1119ACN
43	GEDYT	Edmonton		Argentina	T5R1W2
44	The Queen Elizabeth Hospital	Adelaide		Australia	5011
45	Box Hill Hospital	Box Hill		Australia	3128
46	St Vincent's hospital	Darlinghurst		Australia	2010
47	Western Health	Footscray		Australia	3011
48	Royal Melbourne Hospital	Parkville		Australia	3050
49	Nepean Hospital	Penrith		Australia	2747
50	Royal Perth Hospital	Perth		Australia	6000
51	Mater Hospital Brisbane (Inflammatory Bowel Diseases)	South Brisbane		Australia	4101
52	Kepler Universitätsklinikum GmbH	Linz		Austria	4020
53	Klinikum Wels-Grieskirchen	Wels		Austria	4600
54	Imelda Ziekenhuis	Bonheiden		Belgium	2820
55	CHU Saint-Pierre	Bruxelles		Belgium	1000
56	Cliniques Universitaires Saint-Luc	Bruxelles		Belgium	1200
57	AZ Maria Middelares	Gent		Belgium	9000
58	CHU de Liège	Liege		Belgium	4000
59	CHC MontLegia	Liège		Belgium	4000
60	Az Sint-Maarten	Mechelen		Belgium	2800
61	Vitaz	Sint-Niklaas		Belgium
62	Hospital Das Clinicas Da Ufmg	Belo Horizonte - MG		Brazil	30130-100
63	NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul	Porto Alegre		Brazil	90430-001
64	UFRJ-Hospital Universitário Clementino Fraga Filho	Rio de Janeiro		Brazil	21941-913
65	Hospital Nove de Julho	São Paulo		Brazil	01409-902
66	HCFMUSP	São Paulo		Brazil	05403000
67	UMHAT 'Aleksandrovska' EAD	Sofia		Bulgaria	1431
68	Gastroenterology and Internal Medicine Research Institute (GIRI)	Edmonton	Alberta	Canada	T5R 1W2
69	Fraser Clinical Trials Inc.	New Westminster	British Columbia	Canada	V3L 3W4
70	The Gordon & Leslie Diamond Health Care Center	Vancouver	British Columbia	Canada	V5Z 1M9
71	GIRI Gastrointestinal Research Institute	Vancouver	British Columbia	Canada	V6Z 2K5
72	The Medical Arts Health Research Group	Vancouver	British Columbia	Canada	V7M 2H4
73	Winnipeg Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A 1R9
74	Nova Scotia Health Authority	Halifax	Nova Scotia	Canada	B3H 1V7
75	London Health Sciences Centre	London	Ontario	Canada	N6A 5A5
76	Mount Sinai Hospital-Toronto	Toronto	Ontario	Canada	M5G 1X5
77	St. Jerome Medical Research	Saint-Jerome	Quebec	Canada	J7Z 5T3
78	Viable Clinical Research	Bridgewater		Canada	B4V 3N2
79	Foothills Hospital	Calgary		Canada	T2N4N1
80	Viable Clinical Research	Dartmouth		Canada	B2W 6L4
81	Hospital Clinico Regional Dr. Guillermo Grant Benavente	Concepcion		Chile	4030000
82	Clínica Dermacross S.A.	Santiago de Chile		Chile	7640881
83	Centro de Estudios Clínicos e Investigación Médica (CeCim)	Santiago		Chile	8331143
84	Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital	Guangzhou		China	510000
85	Nanfang Hospital of Southern Medical Hospital	Guangzhou		China	510515
86	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou		China	310016
87	Fakultni nemocnice Brno	Brno		Czechia	625 00
88	Klinicke centrum ISCARE	Praha 9		Czechia	190 00
89	Detska klinika Masarykovy nemocnice v Usti nad Labem	Usti nad Labem		Czechia	401 11
90	Herlev Hospital, University of Copenhagen	Herlev		Denmark	2730
91	Odense Universitetshospital	Odense		Denmark	5000
92	Tartu University Hospital	Tartu		Estonia	50406
93	CHU Amiens - Hopital Sud	AMIENS cedex 1		France	80054
94	Hopital Ambroise Paré - APHP Hôpitaux Universitaires Paris I - Oncologie Thoracique	Boulogne-Billancourt Cedex		France	92104
95	Hôpital Beaujon	Clichy		France	92110
96	CHU Grenoble	Grenoble		France	38700
97	CHU de Nantes hôtel-Dieu	Nantes		France	44093
98	CHU Rangueil	Toulouse		France	31059
99	Praxis Für Gastroenteroligie	Berlin		Germany	10825
100	Charite Campus Benjamin Franklin	Berlin		Germany	12200
101	University Hospital Dresden	Dresden		Germany	1307
102	Universitaetsklinik Erlangen	Erlangen		Germany	91054
103	Universitaetsklinikum Essen	Essen		Germany	45147
104	Klinikum Fulda - Tumorklinik - Germany	Fulda		Germany	36043
105	Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk	Halle Saale		Germany	06120
106	Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd	Heidelberg		Germany	69115
107	Universitätsklinikum Jena	Jena		Germany	07747
108	Gastroenterologie Opernstraße	Kassel		Germany	34117
109	Eugastro GmbH	Leipzig		Germany	04103
110	Gemeinschaftspraxis Mainz Mitte am Gesundheitscentrum Mainz	Mainz		Germany	55116
111	Klinikum der Universität München	Munich		Germany	81377
112	Medius Klinik Nürtingen	Nürtingen		Germany	72622
113	Siloah St. Trudpert Klinikum	Pforzheim		Germany	75179
114	Universitätsklinikum Würzburg	Würzburg		Germany	97080
115	General Hospital of Athens 'G. Gennimatas'	Athens		Greece	15669
116	Hippokration Hospital	Thessaloniki		Greece	54642
117	Obudai Egeszsegugyi Centrum Kft.	Budapest		Hungary	1036
118	Semmelweis Egyetem	Budapest		Hungary	1082
119	Bugat Pal Korhaz	Gyongyos		Hungary	3200
120	Szegedi Tudomanyegyetem	Szeged		Hungary	H-6720
121	Markusovszky Egyetemi Oktatokorhaz	Szombathely		Hungary	H-9700
122	Yashoda Super Speciality Hospitals	Secunderabad		India	500003
123	Shaare Zedek Medical Center	Jerusalem		Israel	9103102
124	Ospedale San Raffaele	Milano		Italy	20132
125	Ospedale Specializzato in Gastroenterologia Saverio de Bellis	Monopoli		Italy	70043
126	Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato	Monserrato		Italy	09042
127	Yeungnam University Hospital	Daegu		Korea, Republic of	42415
128	Chungnam National University Hospital	Daejeon		Korea, Republic of	35015
129	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si		Korea, Republic of	18450
130	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	06273
131	Vilnius University Hospital Santaros Klinikos, Public Institution	Vilnius		Lithuania	LT-08661
132	Clinica de Higado	Cuernavaca		Mexico
133	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara		Mexico	44650
134	Medical Care & Research SA de CV	Merida		Mexico	97070
135	Centro Regiomontano de Estudios Clínicos Roma S.C.	Monterrey		Mexico	64610
136	Albert Schweitzer Ziekenhuis	Dordrecht		Netherlands	3318 AT
137	Erasmus MC	Rotterdam		Netherlands	3015 GD
138	Ikazia Ziekenhuis	Rotterdam		Netherlands	3083 AN
139	Sykehuset Immlandet HF Gjøvik	Gjøvik		Norway	2819
140	Oslo University Hospital HF Ullevål sykehus	Oslo		Norway	0450
141	St. Olavs Hospital	Trondheim		Norway	7030
142	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy	Bydgoszcz		Poland	85-164
143	Pracownia Endoskopowa Szpital Zakonu Bonifratrow sw. Jana Bozego w Lodzi sp. z o.o.	Lodz		Poland	93-357
144	Military Medical Academy, Clinic for Psychiatry	Belgrade		Serbia	11000
145	Special hospital for Internal diseases, Oncomed system	Belgrade		Serbia	11000
146	University Clinical Center of Serbia	Belgrade		Serbia	11000
147	Zvezdara University Medical Center	Belgrade		Serbia	11000
148	Clinic for hematology, Clinical Center Bezanijska Kosa	Belgrade		Serbia	11080
149	General Hospital Vrsac	Vrsac		Serbia	26300
150	General Hospital 'Djordje Joanovic'	Zrenjanin		Serbia	23000
151	FNsP F.D.R. Banska Bystrica	Banska Bystrica		Slovakia	975 17
152	Splosna bolnisnica Celje	Celje		Slovenia	3000
153	Univerzitetni klinicni center Ljubljana	Ljubljana		Slovenia	1000
154	Hosp. de Navarra	Pamplona		Spain	31008
155	Corporacio Sanitari Parc Tauli	Sabadell		Spain	8208
156	Hosp. Univ. Marques de Valdecilla	Santander		Spain	39008
157	Karolinska University Hospital	Solna		Sweden	17176
158	Universitatsspital Basel	Basel		Switzerland	4056
159	INSELSPITAL, Universitätsspital Bern	Bern		Switzerland	3010
160	Gastroenterologische Praxis Balsiger und Seibold	Bern		Switzerland	3012
161	Spital Bülach	Bülach		Switzerland	8180
162	Hopitaux Universitaires de Geneve	Geneva		Switzerland	1205
163	UniversitaetsSpital Zuerich	Zuerich		Switzerland	8091
164	National Cheng Kung University Hospital	Tainan		Taiwan	70403
165	Airedale General Hospital	Keighley		United Kingdom	BD20 6TD
166	Whipps Cross University Hospital	London		United Kingdom	E111NR
167	Guy's and St Thomas' Hospital	London		United Kingdom	SE1 7EH
168	North Tyneside General Hospital	Newcastle		United Kingdom	NE29 8NH

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT05242471

Other Study ID Numbers:

CR109178
2021-003314-39
78934804CRD2001

First Posted:

Feb 16, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Golimumab

Study Results

No Results Posted as of Jul 18, 2022