Trial Outcomes & Findings for A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection (NCT NCT05784129)

Last Updated: 2025-04-29

Results Overview

Endoscopic recurrence was defined by modified Rutgeerts score greater than or equal to (\>=) i2a in neo-terminal ileum, anastomotic site, or its equivalent in gastrointestinal (GI) tract (e.g., colonic ulceration). The modified Rutgeerts score ranged from i0 to i4, where i0 (No lesions), i1 (less than \[\<\] 5 aphthous lesions), i2 (greater than \[\>\] 5 aphthous lesions with normal mucosa between lesions or skip areas of larger lesions or lesions confined to ileocolonic anastomosis \[\<1 centimeter (cm) in length\]), i2a (lesions confined to ileocolonic anastomosis \[including anastomotic stenosis\]), i2b (more than 5 aphthous ulcers or larger lesions, with normal mucosa in-between, in the neoterminal ileum \[with or without anastomotic lesions\]), i3 (diffuse aphthous ileitis with diffusely inflamed mucosa), i4 (large ulcers with diffuse mucosal inflammation or nodules or stenosis in neoterminal ileum). Higher score indicated worsening.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

Baseline (Day 1) up to Week 48

Results posted on

2025-04-29

Participant Flow

A total of 4 participants who had recently undergone a surgical resection for Crohn's Disease (CD) were enrolled, randomized (1:1) and treated with study drug or placebo.

Due to early termination of the study, treatment period was up to Week 16 only. Participants were followed up for safety analysis till Week 28. The planned efficacy analysis was not performed due to the early study termination for reasons unrelated to safety or efficacy.

Participant milestones

Participant milestones
Measure	Guselkumab 200 mg + Guselkumab 100 mg Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16).	Placebo Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16)
Overall Study STARTED	2	2
Overall Study Treated at Weeks 0, 8 and 16	1	2
Overall Study Treated at Weeks 0, 8	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Guselkumab 200 mg + Guselkumab 100 mg Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16).	Placebo Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16)
Overall Study Study terminated by sponsor	2	2

Baseline Characteristics

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=4 Participants Participants received guselkumab 200 mg or matching placebo SC injection at Week 0 followed by guselkumab 100 mg or matching placebo SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16).
Age, Continuous	46.3 Years STANDARD_DEVIATION 6.75 • n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	4 Participants n=5 Participants
Age, Customized From 65 to 84 years	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Week 48

Population: As no participant was available for the analysis due to early termination of study, no data was collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 48

Population: Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure.

Clinical remission without disease recurrence at Week 48 was a composite endpoint defined by (1) Crohn's disease activity index (CDAI) \<150 at Week 48 \& (2) no endoscopic recurrence as defined by modified Rutgeerts score \< i2a by Week 48 \& (3) have not experienced disease recurrence. Disease recurrence was defined as (1) \>=70 point increase from baseline in CDAI score at \>8 weeks after randomization \& CDAI score \>=200 and evidence of endoscopic recurrence (Rutgeerts score \<i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of \>5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 48

Population: Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure.

Disease recurrence was defined by (1) a \>=70 point increase from baseline in CDAI score at \>8 weeks after randomization \& CDAI score \>=200 and evidence of endoscopic recurrence (Rutgeerts score \<i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of \>5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 48

Population: Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure.

Abdominal pain free at Week 48 is defined as abdominal pain (AP) score = 0 at Week 48. The scoring was done on a 4-point scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 48

Population: Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure.

Time-to-recurrence of symptoms was defined as time to attaining an AP mean daily score \>1 (and also \>1 point higher than baseline) along with stool frequency (SF) mean daily score \>3 (and also \>3 higher per day than baseline) for 2 consecutive weeks through Week 48. AP score scaling was done on a 4-point score scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain. Stool frequency score was calculated from the total number of liquid or very soft stools in the previous 7 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) up to early termination of trial (up to Week 28)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received.

Number of participants with TEAEs and TESAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE was an AE 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. Any AE/SAE occurring at or after the initial administration of study intervention through early termination of trial (up to Week 28) was considered to be treatment emergent.

Outcome measures

Outcome measures
Measure	Guselkumab 200 mg + Guselkumab 100 mg n=2 Participants Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16).	Placebo n=2 Participants Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	1 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At Weeks 0, 8, 16

Population: Pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of study intervention, and had at least 1 valid blood sample drawn postbaseline for PK analysis and were analyzed according to the study intervention received. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed at specified categories.

Serum guselkumab concentrations over time were reported. No summary analysis was done as study was terminated early and participant wise data were reported. This outcome measure was planned to be analyzed for "Guselkumab 200 mg + Guselkumab 100 mg" arm only.

Outcome measures

Outcome measures
Measure	Guselkumab 200 mg + Guselkumab 100 mg n=2 Participants Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16).	Placebo Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16)
Serum Guselkumab Concentrations Over Time Participant 1 (Week 8)	1.68920 micrograms/milliliters (ug/mL)	—
Serum Guselkumab Concentrations Over Time Participant 1 (Week 16)	0.70957 micrograms/milliliters (ug/mL)	—
Serum Guselkumab Concentrations Over Time Participant 2 (Week 0)	0 micrograms/milliliters (ug/mL)	—
Serum Guselkumab Concentrations Over Time Participant 2 (Week 8)	2.87917 micrograms/milliliters (ug/mL)	—
Serum Guselkumab Concentrations Over Time Participant 1 (Week 0)	0 micrograms/milliliters (ug/mL)	—

SECONDARY outcome

Timeframe: At Week 48

Population: Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure.

Steroid free clinical remission at Week 48 is defined as CDAI \<150 and no corticosteroids within 30 days. The CDAI was a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was 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. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicated higher disease activities.

Outcome measures

Outcome data not reported

Adverse Events

Guselkumab 200 mg + Guselkumab 100 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Guselkumab 200 mg + Guselkumab 100 mg n=2 participants at risk Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16).	Placebo n=2 participants at risk Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16)
Infections and infestations Campylobacter Gastroenteritis	0.00% 0/2 • Baseline (Day 1) up to 12 weeks after last study dose administration (up to Week 28) Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received.	50.0% 1/2 • Number of events 1 • Baseline (Day 1) up to 12 weeks after last study dose administration (up to Week 28) Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received.
Renal and urinary disorders Nephrolithiasis	50.0% 1/2 • Number of events 1 • Baseline (Day 1) up to 12 weeks after last study dose administration (up to Week 28) Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received.	0.00% 0/2 • Baseline (Day 1) up to 12 weeks after last study dose administration (up to Week 28) Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received.

Other adverse events

Adverse event data not reported

Additional Information

Medical Director Gastroenterology

Janssen Pharmaceuticals, Inc, US Medical Affairs

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER