PRISM: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Terminated

CT.gov ID

NCT04102111

Collaborator

(none)

Enrollment

Locations

Arms

26.7

Actual Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Drug: JNJ-67864238 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease

Actual Study Start Date :

Sep 23, 2019

Actual Primary Completion Date :

Nov 17, 2021

Actual Study Completion Date :

Dec 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-67864238 Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.	Drug: JNJ-67864238 Participants will receive oral tablets of JNJ-67864238 twice daily.
Placebo Comparator: Placebo Participants will receive oral tablets of matching placebo twice daily for 12 weeks.	Drug: Placebo Participants will receive oral tablets of matching placebo twice daily.

Arm

Intervention/Treatment

Experimental: JNJ-67864238

Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.

Drug: JNJ-67864238

Participants will receive oral tablets of JNJ-67864238 twice daily.

Placebo Comparator: Placebo

Participants will receive oral tablets of matching placebo twice daily for 12 weeks.

Drug: Placebo

Participants will receive oral tablets of matching placebo twice daily.

Outcome Measures

Primary Outcome Measures

Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [Baseline and Week 12]
CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being) with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant in a diary. A decrease in CDAI over time indicates improvement in disease activity.

Secondary Outcome Measures

Change From Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) at Week 12 [Baseline and Week 12]
SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 [remission] to 60 [the most severe endoscopic activity]).
Percentage of Participants with Clinical Response at Week 12 [Week 12]
Percentage of participants with clinical response at Week 12 will be assessed. Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI or CDAI less than (<) 150.
Percentage of Participants with Clinical Remission at Week 12 [Week 12]
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as a CDAI score of < 150 points.
Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 12 [Week 12]
Percentage of participants with PRO-2 remission at Week 12 will be assessed. PRO-2 remission is defined as abdominal pain (AP) mean daily score (AP component of the CDAI) less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 3.
Percentage of Participants with Endoscopic Response at Week 12 [Week 12]
Percentage of participants with endoscopic response at Week 12 will be assessed. Endoscopic response is defined as at least a 50 percent (%) improvement from baseline in the SES-CD.
Percentage of Participants with Endoscopic Remission at Week 12 [Week 12]
Percentage of participants with endoscopic remission at Week 12 will be assessed. Endoscopic remission is defined as an SES-CD score <= 2.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450
Have evidence of active ileocolonic Crohn's disease as assessed by an Simplified Endoscopic Score for Crohn's disease (SES-CD) score >=3 at screening by central endoscopy reading; or an elevated screening C-reactive protein (CRP) (greater than [>] 0.3 milligrams per deciliter [mg/dL] or 3.0 milligrams per liter [mg/L]) or an elevated screening fecal calprotectin (>250 micrograms per mg [mcg/mg])
A participant with a family history of colorectal cancer, personal history of increased risk of colorectal cancer, age > 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening). Adenomatous polyps must be removed before the first administration of the study intervention
A woman of childbearing potential must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [beta-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
Has previously demonstrated inadequate response to, loss of response to, or intolerance to an approved biologic therapy (unless otherwise specified in the JNJ-67864238 intervention cohort specific criteria, that is, anti-tumor necrosis factor (TNF) alpha agents (for example, infliximab, adalimumab, certolizumab pegol], anti- interleukin (IL)-12/23 agents [for example, ustekinumab], or anti-integrin agents [for example, vedolizumab]) or has previously demonstrated an inadequate response to or failed to tolerate corticosteroids or immunomodulators (that is, 6-mercaptopurine [6-MP], azathioprine [AZA], and methotrexate [MTX]) but not a biologic, that is, the biologic nonfailures (Bio-NF) population
Therapy for the treatment of Crohn's disease must include at least 1 of the following medications, which should have been maintained at stable doses prior to the baseline (Week 0) visit: (a) Oral 5-aminosalicylic acid (5-ASA) compounds; (b) Oral corticosteroids at a prednisone-equivalent dose <= 25 milligrams per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate; (c) Antibiotics being used as a primary treatment of Crohn's disease; and (d) Conventional immunomodulators (that is, AZA, 6-MP, or MTX) if participants have been taking them for at least 12 weeks and have been at a stable dose for at least 4 weeks prior to baseline

Exclusion Criteria:

Prior exposure to an anti-IL-12/23 (that is ustekinumab) or anti-IL-23 agents or related compound (including risankizumab, brazikumab, guselkumab, mirikizumab, and related compounds). Exception is made for participants who have had minimal exposure to ustekinumab at its approved labeled dosage and have met the required wash-out criteria and have not demonstrated inadequate response or intolerance to ustekinumab
Known allergies, hypersensitivity, or intolerance to JNJ-67864238 or its excipients
Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with JNJ-67864238
Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
Initiation of total (complete) or partial (supplemental) parenteral nutrition administered through any indwelling catheter less than (<) 3 weeks before baseline or anticipated to require parenteral nutrition administered through an indwelling catheter during enrollment in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peak Gastroenterology Associates	Colorado Springs	Colorado	United States	80920
2	Gastro Florida	Clearwater	Florida	United States	33756
3	Gastroenterology Associates of Central GA	Macon	Georgia	United States	31201
4	CroNOLA, LLC	Houma	Louisiana	United States	70360
5	Washington University	Saint Louis	Missouri	United States	63110
6	NYU Langone Long Island Clinical Research Associates	Lake Success	New York	United States	11042
7	Columbia University Medical Center	New York	New York	United States	10032
8	Northshore Gastroenterology Research, LLC	Beachwood	Ohio	United States	44122
9	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	United States	44060
10	Northshore Gastroenterology Research, LLC	Westlake	Ohio	United States	44145
11	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma	United States	73112
12	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212
13	Gastroenterology Research of San Antonio	San Antonio	Texas	United States	78229
14	Cer Instituto Medico	Buenos Aires		Argentina	1878
15	CINME - Centro de Investigaciones Metabolicas	Caba		Argentina	C1027AAP
16	Clínica Adventista Belgrano	Ciudad De Buenos Aires		Argentina	C1430EGF
17	Sanatorio Duarte Quiroz	Cordoba		Argentina	X5002AOQ
18	Centro de Investigaciones Medicas Mar Del Plata	Mar Del Plata		Argentina	B7600FYK
19	Fundación de Estudios Clínicos	Rosario		Argentina	2000
20	Universitatsklinikum Schleswig-Holstein - Kiel	Kiel		Germany	24105
21	Eugastro GmbH	Leipzig		Germany	04103
22	Universitatsklinikum Mannheim	Mannheim		Germany	68167
23	Universitätsklinikum Ulm, Klinik für Innere Medizin II	Ulm		Germany	89081
24	Policlinico di Bari Ospedale Giovanni XXIII	Bari		Italy
25	Policlinico Sant'Orsola Malpighi	Bologna		Italy	40138
26	Azienda Ospedaliera G. Brotzu	Cagliari		Italy	09134
27	Azienda Ospedaliera Universitaria Careggi	Firenze		Italy	50134
28	Ospedale Policlinico San Martino IRCCS	Genova		Italy	16132
29	Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar	Negrar ( Ve)		Italy	37024
30	Ospedale Maggiore della Carità	Novara		Italy	28100
31	Azienda Ospedaliera di Padova	Padova		Italy	35128
32	IRCCS Policlinico San Matteo, Università degli studi di Pavi	Pavia		Italy	27100
33	Azienda Ospedaliera Universitaria Pisana	Pisa		Italy	56124
34	Azienda Ospedaliera G.Salvini Ospedale di Rho	RHO		Italy
35	Policinico A Gemelli	Roma		Italy	00168
36	Istituto Clinico Humanitas	Rozzano		Italy	20089
37	A.O.Citta della Salute e della Scienza di Torino	Torino		Italy	10126
38	Gastromed Kralisz Romatowski Stachurska Sp. j.	Bialystok		Poland	15-322
39	Endoskopia Sp z o.o.	Sopot		Poland	81-756
40	Centralny Szpital Kliniczny Mswia	Warsaw		Poland	02-507
41	WIP Warsaw IBD Point Profesor Kierkus	Warszawa		Poland	00-728
42	Wojskowy Instytut Medyczny	Warszawa		Poland	04-349
43	Medical Center Meditsinskie Tekhnologii	Ekaterinburg		Russian Federation	620075
44	Immanuel Kant Baltic Federal University	Kaliningrad		Russian Federation	236016
45	Kemerovo Region Clinical Hospital	Kemerovo		Russian Federation	650066
46	City Hospital #13 of Avtozavodsky	Nizhniy Novgorod		Russian Federation	603018
47	Medical Center SibNovoMed LLC	Novosibirsk		Russian Federation	630005
48	Rostov State Medical University (RSMU) based on City Hospital No. 20	Rostov-on-Don		Russian Federation	344091
49	City Hospital named after St. Martyr Elizabeth	Saint-Petersburg		Russian Federation	195257
50	Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways'	Samara		Russian Federation	443029
51	International Medical Centre SOGAZ	St-Petersburg		Russian Federation	191186
52	GBUZ Respublican Clinical Hospital n.a. GG Kuvatova	Ufa		Russian Federation	450005
53	Medical diagnostic centre LTD 'MDC'	Yaroslavl		Russian Federation	150062
54	MNCE'City Clinical Hospital №2 named after prof. O.O. Shalimov' of the Kharkiv City Council	Kharkiv		Ukraine	61037
55	GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine	Kharkiv		Ukraine	61039
56	Kyivska miska klinichna likarnia 18	Kyiv		Ukraine	01030
57	Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC	Kyiv		Ukraine	02000
58	Danylo Halytsky Lviv National Medical University	Lviv		Ukraine	79010
59	Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council	Odesa		Ukraine	65025
60	Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council	Ternopil		Ukraine	46002
61	MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council	Uzhgorod		Ukraine	88000
62	Medical Center Ltd 'Health Clinic'	Vinnytsya		Ukraine	21009
63	VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council	Vinnytsya		Ukraine

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:

NCT04102111

Other Study ID Numbers:

CR108455
2018-000649-38
67864238PACRD2001
PLATFORMPACRD2001
2019-003335-37

First Posted:

Sep 25, 2019

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 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:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Jan 24, 2022