Trial Outcomes & Findings for A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT04397263)
NCT ID: NCT04397263
Last Updated: 2025-10-17
Results Overview
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.
COMPLETED
PHASE3
38 participants
From baseline (Week 0) up to Week 48
2025-10-17
Participant Flow
Upon completion of the open-label treatment phase, participants were permitted to enter the long-term extension (LTE) phase. The LTE phase is ongoing and results will be published after the completion of the study.
Participant milestones
| Measure |
Guselkumab 200 Milligrams (mg)
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Guselkumab 200 Milligrams (mg)
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
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Baseline Characteristics
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Age, Continuous
|
42.0 years
STANDARD_DEVIATION 14.58 • n=5 Participants
|
|
Sex: Female, Male
Female
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14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
33 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
3 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (increased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (increased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (decreased): Grade 1
|
18 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (increased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (increased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Neutrophils (decreased): Grade 2
|
7 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (increased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (decreased): Grade 2
|
2 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (decreased): Grade 3
|
3 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Hemoglobin (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (increased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (decreased): Grade 1
|
5 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (decreased): Grade 2
|
7 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (decreased): Grade 3
|
4 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Lymphocytes (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Neutrophils (decreased): Grade 1
|
7 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Neutrophils (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Neutrophils (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Platelets (decreased): Grade 1
|
1 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Platelets (decreased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Platelets (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Platelets (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (increased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (increased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (increased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (decreased): Grade 1
|
9 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (decreased): Grade 2
|
9 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Total WBC Count (decreased): Grade 4
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Albumin (decreased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Albumin (decreased): Grade 2
|
1 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (increased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Creatinine (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Glucose (decreased): Grade 1
|
1 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Glucose (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (increased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (increased): Grade 2
|
1 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (increased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (decreased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (decreased): Grade 2
|
5 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Potassium (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (increased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (increased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (increased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (decreased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (decreased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Sodium (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Glucose (decreased): Grade 2
|
1 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Glucose (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Albumin (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Albumin (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (increased): Grade 1
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (increased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (increased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (decreased): Grade 1
|
3 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (decreased): Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (decreased): Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Corrected Calcium (decreased): Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Creatinine (increased): Grade 1
|
2 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Creatinine (increased): Grade 2
|
1 Participants
|
|
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Creatinine (increased): Grade 3
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Number of Participants With TEAEs of Infections
|
11 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
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Number of Participants With TEAEs of Injection-site Reactions
|
3 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
|
Number of Participants With TEAEs Temporally Associated With Infusion
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
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|---|---|
|
Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
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.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs
|
0 Participants
|
PRIMARY outcome
Timeframe: From screening (Week -8) up to Week 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants with concomitant medications for Crohn's disease were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Concomitant Medications for Crohn's Disease
Oral amino salicylates
|
28 Participants
|
|
Number of Participants With Concomitant Medications for Crohn's Disease
6- mercaptopurine/azathioprine
|
16 Participants
|
|
Number of Participants With Concomitant Medications for Crohn's Disease
oral corticosteroids
|
12 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants with clinical response through Week 48 were reported. Clinical response was defined as a greater than or equal to (\>=) 100-point reduction from baseline in CDAI score or CDAI score less than \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Clinical Response Through Week 48
Week 4
|
20 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 20
|
28 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 24
|
30 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 32
|
29 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 36
|
29 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 44
|
29 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 48
|
31 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 8
|
25 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 12
|
30 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 16
|
28 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 28
|
29 Participants
|
|
Number of Participants With Clinical Response Through Week 48
Week 40
|
28 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants with clinical remission through Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Clinical Remission Through Week 48
Week 4
|
17 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 8
|
19 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 12
|
23 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 16
|
23 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 20
|
22 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 24
|
25 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 28
|
25 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 32
|
25 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 36
|
26 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 40
|
23 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 44
|
25 Participants
|
|
Number of Participants With Clinical Remission Through Week 48
Week 48
|
29 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants with PRO-2 remission through Week 48 were reported. PRO-2 remission was defined as abdominal pain (AP) mean daily score at or below 1 and stool frequency (SF) mean daily score at or below 3, and no worsening of AP or SF from baseline. Mean daily AP score was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores score at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 4
|
6 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 32
|
19 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 36
|
20 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 40
|
21 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 44
|
23 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 8
|
12 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 12
|
16 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 16
|
16 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 20
|
19 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 24
|
18 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 28
|
21 Participants
|
|
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Week 48
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
Change from baseline in SES-CD score at Week 48 were reported. The SES-CD score was used to evaluate endoscopic improvement. The SES-CD was 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 was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for the narrowing component which only attain a maximum total score of 11 because, the presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48
|
-6.4 score on a scale
Standard Deviation 7.00
|
SECONDARY outcome
Timeframe: Predose at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 1 hour post dose at Weeks 0, 4, 8Population: Pharmacokinetics (PK) analysis set included all enrolled participants who received at least 1 complete dose of guselkumab and have at least 1 valid blood sample drawn for PK analysis after their first dose of guselkumab. Here, 'n' signifies the number of participants evaluable at each specified timepoint.
Serum concentration of guselkumab were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Serum Concentation of Guselkumab
Week 12: pre-dose
|
9.691 micrograms/milliliter (mcg/mL)
Standard Deviation 4.4559
|
|
Serum Concentation of Guselkumab
Week 16: pre-dose
|
9.143 micrograms/milliliter (mcg/mL)
Standard Deviation 4.3351
|
|
Serum Concentation of Guselkumab
Week 20: pre-dose
|
8.761 micrograms/milliliter (mcg/mL)
Standard Deviation 4.3497
|
|
Serum Concentation of Guselkumab
Week 24: pre-dose
|
8.966 micrograms/milliliter (mcg/mL)
Standard Deviation 4.6369
|
|
Serum Concentation of Guselkumab
Week 32: pre-dose
|
8.381 micrograms/milliliter (mcg/mL)
Standard Deviation 3.7270
|
|
Serum Concentation of Guselkumab
Week 40: pre-dose
|
9.417 micrograms/milliliter (mcg/mL)
Standard Deviation 5.3775
|
|
Serum Concentation of Guselkumab
Week 48: pre-dose
|
8.885 micrograms/milliliter (mcg/mL)
Standard Deviation 4.4065
|
|
Serum Concentation of Guselkumab
Week 0: pre-dose
|
NA micrograms/milliliter (mcg/mL)
Standard Deviation NA
NA signifies that mean were below the lowest quantification (BQL=0) and hence standard deviation (SD) was not calculated.
|
|
Serum Concentation of Guselkumab
Week 0: 1 hour post dose
|
60.567 micrograms/milliliter (mcg/mL)
Standard Deviation 7.8417
|
|
Serum Concentation of Guselkumab
Week 4: pre-dose
|
6.656 micrograms/milliliter (mcg/mL)
Standard Deviation 2.5431
|
|
Serum Concentation of Guselkumab
Week 4: 1 hour post dose
|
63.556 micrograms/milliliter (mcg/mL)
Standard Deviation 10.7183
|
|
Serum Concentation of Guselkumab
Week 8: pre-dose
|
8.679 micrograms/milliliter (mcg/mL)
Standard Deviation 3.1697
|
|
Serum Concentation of Guselkumab
Week 8: 1 hour post dose
|
65.484 micrograms/milliliter (mcg/mL)
Standard Deviation 7.8536
|
SECONDARY outcome
Timeframe: From Week 0 through Week 48Population: Immunogenicity analysis set included all enrolled participants who received at least 1 dose of guselkumab and had at least 1 observed post dose immune response data. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Number of participants with anti-guselkumab antibodies through Week 48 were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=37 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Anti-Guselkumab Antibodies Through Week 48
|
1 Participants
|
SECONDARY outcome
Timeframe: From Week 0 through Week 48Population: Immunogenicity analysis set included all enrolled participants who received at least 1 dose of guselkumab and had at least 1 observed post dose immune response data. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Number of participants with neutralizing-guselkumab antibodies through Week 48 were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=1 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, 'n' signifies number of participants evaluable at each specified timepoints.
Change from baseline in inflammatory PD marker of CRP concentration were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 4
|
-1.65 milligrams per liter (mg/L)
Interval -38.9 to -0.15
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 8
|
-2.20 milligrams per liter (mg/L)
Interval -36.55 to -0.25
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 12
|
-2.40 milligrams per liter (mg/L)
Interval -44.2 to -0.2
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 16
|
-0.90 milligrams per liter (mg/L)
Interval -44.1 to -0.3
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 20
|
-0.70 milligrams per liter (mg/L)
Interval -45.2 to 0.2
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 24
|
-1.60 milligrams per liter (mg/L)
Interval -45.1 to -0.2
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 32
|
-1.25 milligrams per liter (mg/L)
Interval -30.5 to -0.4
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 40
|
-1.05 milligrams per liter (mg/L)
Interval -31.9 to -0.2
|
|
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Week 48
|
-1.65 milligrams per liter (mg/L)
Interval -33.4 to -0.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 8, 12, 24, and 48Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, 'n' signifies number of participants evaluable at each specified timepoint.
Change from baseline in inflammatory PD marker of FC levels were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
Week 4
|
-270.0 milligrams per kilogram (mg/kg)
Interval -817.0 to -45.0
|
|
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
Week 8
|
-252.5 milligrams per kilogram (mg/kg)
Interval -1614.5 to -79.0
|
|
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
Week 12
|
-380.0 milligrams per kilogram (mg/kg)
Interval -1563.0 to -110.0
|
|
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
Week 24
|
-310.0 milligrams per kilogram (mg/kg)
Interval -1722.0 to -87.0
|
|
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
Week 48
|
-280.0 milligrams per kilogram (mg/kg)
Interval -1678.0 to -123.0
|
SECONDARY outcome
Timeframe: At Week 48Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
Change from baseline in CDAI score at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=33 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
<= 1st Quartile Concentration
|
-171.7 score on a scale
Standard Deviation 152.12
|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 1st Quartile and <= 2nd Quartile Concentration
|
-137.6 score on a scale
Standard Deviation 74.78
|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
>2nd Quartile and <= 3rd Quartile Concentration
|
-157.5 score on a scale
Standard Deviation 124.85
|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 3rd Quartile Concentration
|
-146.0 score on a scale
Standard Deviation 111.21
|
SECONDARY outcome
Timeframe: At Week 48Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
Number of participants in clinical response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical response was defined as a \>=100-point reduction from baseline in CDAI score or CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=33 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 1st Quartile and <= 2nd Quartile Concentration
|
8 Participants
|
|
Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
>2nd Quartile and <= 3rd Quartile Concentration
|
7 Participants
|
|
Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
<= 1st Quartile Concentration
|
8 Participants
|
|
Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 3rd Quartile Concentration
|
8 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
Number of participants in clinical remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=33 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 3rd Quartile Concentration
|
8 Participants
|
|
Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
<= 1st Quartile Concentration
|
7 Participants
|
|
Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 1st Quartile and <= 2nd Quartile Concentration
|
7 Participants
|
|
Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
>2nd Quartile and <= 3rd Quartile Concentration
|
7 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
Number of participants in endoscopic response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic response was defined as \>=50 % improvement from baseline in SES-CD score or SES-CD score less than or equal to (\<=) 2. The SES-CD was based on 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 was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores across all segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=33 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
<= 1st Quartile Concentration
|
4 Participants
|
|
Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 1st Quartile and <= 2nd Quartile Concentration
|
4 Participants
|
|
Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
>2nd Quartile and <= 3rd Quartile Concentration
|
5 Participants
|
|
Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 3rd Quartile Concentration
|
5 Participants
|
SECONDARY outcome
Timeframe: At Week 48Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
Number of participants in endoscopic remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic remission: an SES-CD score \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual subcomponent. The SES-CD was based on 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 was scored from 0 (best) to 3 (worst) for each segment, resulting in total score of 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores (all segments) \& it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=33 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 1st Quartile and <= 2nd Quartile Concentration
|
3 Participants
|
|
Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
>2nd Quartile and <= 3rd Quartile Concentration
|
4 Participants
|
|
Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
> 3rd Quartile Concentration
|
4 Participants
|
|
Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
<= 1st Quartile Concentration
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Change from baseline in the average daily P.Eq oral corticosteroid dose (excluding Budesonide) through Week 48 among participants receiving oral corticosteroids other than Budesonide at baseline were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=4 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
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
Week 4
|
0.00 milligram per day (mg/day)
Standard Deviation 0.000
|
|
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
Week 8
|
0.00 milligram per day (mg/day)
Standard Deviation 0.000
|
|
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
Week 12
|
0.00 milligram per day (mg/day)
Standard Deviation 0.000
|
|
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
Week 16
|
-9.06 milligram per day (mg/day)
Standard Deviation 6.722
|
|
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
Week 20
|
-13.13 milligram per day (mg/day)
Standard Deviation 8.509
|
|
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
Week 24
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
|
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
Week 28
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
|
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
Week 32
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
|
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
Week 36
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
|
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
Week 40
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
|
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
Week 44
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
|
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
Week 48
|
-13.75 milligram per day (mg/day)
Standard Deviation 7.500
|
SECONDARY outcome
Timeframe: At Week 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants not receiving concomitant corticosteroids at Week 48 among participants receiving concomitant corticosteroids at baseline were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants not receiving concomitant corticosteroids for at least 30 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
Number of participants not receiving concomitant corticosteroids for at least 90 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.
Outcome measures
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 Participants
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
|
9 Participants
|
Adverse Events
Guselkumab 200 Milligrams (mg)
Serious adverse events
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 participants at risk
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
2.6%
1/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Gastrointestinal disorders
Proctitis
|
2.6%
1/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.6%
1/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
Other adverse events
| Measure |
Guselkumab 200 Milligrams (mg)
n=38 participants at risk
Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug.
|
|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Gastrointestinal disorders
Dental Caries
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
General disorders
Injection Site Bruising
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
General disorders
Pyrexia
|
39.5%
15/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
4/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Infections and infestations
Tinea Pedis
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Nervous system disorders
Headache
|
15.8%
6/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • All cause mortality: From screening (Week -8) up to Week 48; SAEs and Other AEs: From baseline (Week 0) up to Week 48
Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
|
Additional Information
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