Clinical trial NCT04397263: A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Crohns Disease
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With TEAEs of Infections
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With TEAEs of Injection-site Reactions
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With TEAEs Temporally Associated With Infusion
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs
timeFrame: From baseline (Week 0) up to Week 48
measure: Number of Participants With Concomitant Medications for Crohn's Disease
timeFrame: From screening (Week -8) up to Week 48
Secondary outcomes:
measure: Number of Participants With Clinical Response Through Week 48
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
measure: Number of Participants With Clinical Remission Through Week 48
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
measure: Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
measure: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48
timeFrame: Baseline (Week 0) and Week 48
measure: Serum Concentation of Guselkumab
timeFrame: Predose at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 1 hour post dose at Weeks 0, 4, 8
measure: Number of Participants With Anti-Guselkumab Antibodies Through Week 48
timeFrame: From Week 0 through Week 48
measure: Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48
timeFrame: From Week 0 through Week 48
measure: Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
timeFrame: Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48
measure: Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
timeFrame: Baseline (Week 0), Weeks 4, 8, 12, 24, and 48
measure: Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
timeFrame: At Week 48
measure: Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
timeFrame: At Week 48
measure: Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
timeFrame: At Week 48
measure: Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
timeFrame: At Week 48
measure: Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
timeFrame: At Week 48
measure: 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
timeFrame: Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
measure: Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
timeFrame: At Week 48
measure: Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
timeFrame: Up to Week 48
measure: Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Abiko
country: Japan
facility: KOKIKAI Tokatsu Tsujinaka Hospital
city: Bunkyo ku
country: Japan
facility: Institute of Science Tokyo Hospital
city: Hitachi
country: Japan
facility: Hitachi General Hospital
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Kamakura
country: Japan
facility: Ofuna Chuo Hospital
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Nara
country: Japan
facility: Kenseikai Dongo Hospital
city: Nishinomiya shi
country: Japan
facility: Hyogo Medical University Hospital
city: Oita
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Saitama Medical Center
city: Sapporo
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sendai Miyagi
country: Japan
facility: Sendai Kosei Hospital
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyohashi
country: Japan
facility: National Hospital Organization Toyohashi Medical Center
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: