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

NCT04397263 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CR108801CNTO1959CRD3003
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Crohns Disease

Outcome Measures

Primary Outcomes (11)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs (TEAEs) were AEs with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. All TEAEs including serious and non-serious AEs were reported.

  From baseline (Week 0) up to Week 48

• Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

  Number of participants with TESAEs were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. A serious adverse event (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.

  From baseline (Week 0) up to Week 48

• Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)

  Number of participants with TEAESI was reported. Active tuberculosis (TB) or malignancies were considered as TEAESIs. TEAESIs were AESIs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters

  Number of participants with treatment-emergent abnormalities in hematology laboratory parameters were reported. Laboratory tests included in hematology were hemoglobin, lymphocytes, neutrophils, platelet count, Total WBC (white blood cell) Count. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters

  Number of participants with treatment-emergent abnormalities in chemistry laboratory parameters were reported. Laboratory parameters included in clinical chemistry were albumin, corrected calcium, creatinine, glucose, potassium, sodium. NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With TEAEs of Infections

  Number of participants with TEAEs of infections were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With TEAEs of Injection-site Reactions

  Number of participants with TEAEs of injection-site reactions were reported. A significant injection-site reaction was defined as an adverse reaction that was manifested through 1 or more of the following symptoms: significant bruising, erythema, hemorrhage, irritation, pain, pruritus at the site of injection. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With TEAEs Temporally Associated With Infusion

  Number of participants with TEAEs temporally associated with infusion were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that had worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent

  TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. The Columbia-suicide severity rating scale (C-SSRS) defined was 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as non-suicidal self-injurious behavior and completed suicide. The C-SSRS was an investigator-administered questionnaire: 1) No suicidal ideation or behaviors (including self-injurious behavior without suicidal intent): No further action was needed; 2) Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior; participant risk is assessed by the investigator. 3) Suicidal ideation levels 4 or 5 or any suicidal behavior: participant risk assessed and referral to a mental health professional. If no events qualify for scores of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicated greater severity.

  From baseline (Week 0) up to Week 48

• Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs

  Number of participants with clinically significant treatment-emergent abnormalities in vital signs were reported. Vital signs included weight, pulse rate, temperature, respiratory rate, systolic blood pressure, and diastolic blood pressure. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

  From baseline (Week 0) up to Week 48

• Number of Participants With Concomitant Medications for Crohn's Disease

  Number of participants with concomitant medications for Crohn's disease were reported.

  From screening (Week -8) up to Week 48

Secondary Outcomes (18)

• Number of Participants With Clinical Response Through Week 48

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

• Number of Participants With Clinical Remission Through Week 48

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

• Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

• Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48

  Baseline (Week 0) and Week 48

• Serum Concentation of Guselkumab

  Predose at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 1 hour post dose at Weeks 0, 4, 8

Study Arms (1)

Guselkumab

EXPERIMENTAL

Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.

Also known as: CNTO1959

Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (25)

KOKIKAI Tokatsu Tsujinaka Hospital

Abiko, 270-1168, Japan

Location

Institute of Science Tokyo Hospital

Bunkyō City, 113 8519, Japan

Location

Hitachi General Hospital

Hitachi, 317-0077, Japan

Location

Asahikawa Medical University Hospital

Hokkaido, 078 8510, Japan

Location

Ofuna Chuo Hospital

Kamakura, 247-0056, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, 5960042, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Kenseikai Dongo Hospital

Nara, 635-0022, Japan

Location

Hyogo Medical University Hospital

Nishinomiya Shi, 663 8501, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Ishida Clinic of IBD and Gastroenterology

Ōita, 870 0823, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

Kitasato University Hospital

Sagamihara, 252-0375, Japan

Location

Saitama Medical Center

Saitama, 350 8550, Japan

Location

Sapporo Tokushukai Hospital

Sapporo, 004-0041, Japan

Location

Sendai Kosei Hospital

Sendai Miyagi, 9810914, Japan

Location

Jichi Medical University Hospital

Shimotsuke, 329-0498, Japan

Location

National Center for Global Health and Medicine

Shinjuku- Ku, 162-8655, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, 162-8666, Japan

Location

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, 130 8575, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, 569-8686, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 9308550, Japan

Location

National Hospital Organization Toyohashi Medical Center

Toyohashi, 441-8570, Japan

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: June 10, 2020
• Primary Completion: February 29, 2024
• Study Completion: September 12, 2025
• Last Updated: February 25, 2026
• Results First Posted: May 20, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (25)