Phase 3 N=38 Treatment

A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Crohns Disease

Bottom Line

View on ClinicalTrials.gov: NCT04397263 ↗

Enrolled (actual)

Serious AEs

7.9%

Results posted

May 2025

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 33 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Guselkumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Pharmaceutical K.K.
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs)	33	—
PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	3	—
PRIMARY Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)	—	—
PRIMARY Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters	0; 0; 0; 0; 18; 2	—
PRIMARY Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters	0; 1; 0; 0; 0; 0	—
PRIMARY Number of Participants With TEAEs of Infections	11	—
PRIMARY Number of Participants With TEAEs of Injection-site Reactions	3	—
PRIMARY Number of Participants With TEAEs Temporally Associated With Infusion	—	—
PRIMARY Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent	—	—
PRIMARY Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs	—	—
PRIMARY Number of Participants With Concomitant Medications for Crohn's Disease	28; 16; 12	—
SECONDARY Number of Participants With Clinical Response Through Week 48	20; 25; 30; 28; 28; 30	—
SECONDARY Number of Participants With Clinical Remission Through Week 48	17; 19; 23; 23; 22; 25	—
SECONDARY Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48	6; 12; 16; 16; 19; 18	—
SECONDARY Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48	-6.4	—
SECONDARY Serum Concentation of Guselkumab	NA; 60.567; 6.656; 63.556; 8.679; 65.484	—
SECONDARY Number of Participants With Anti-Guselkumab Antibodies Through Week 48	1	—
SECONDARY Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48	—	—
SECONDARY Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration	-1.65; -2.20; -2.40; -0.90; -0.70; -1.60	—
SECONDARY Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels	-270.0; -252.5; -380.0; -310.0; -280.0	—
SECONDARY Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	-171.7; -137.6; -157.5; -146.0	—
SECONDARY Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	8; 8; 7; 8	—
SECONDARY Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	7; 7; 7; 8	—
SECONDARY Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	4; 4; 5; 5	—
SECONDARY Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	2; 3; 4; 4	—
SECONDARY Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline	0.00; 0.00; 0.00; -9.06; -13.13; -13.75	—
SECONDARY Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline	9	—
SECONDARY Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline	9	—
SECONDARY Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline	9	—

Summary

The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.

Eligibility Criteria

Inclusion Criteria

Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
Have screening laboratory test results within the protocol specified parameters
A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria

Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
Unstable doses of concomitant Crohn's disease therapy
Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
Prior exposure to p40 inhibitors or p19 inhibitors
Any medical contraindications preventing study participation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04397263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.