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CompletedNCT03464136SEAVUEUpdated Apr 29, 2025Results posted

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

A Phase 3 interventional study of Placebo for Ustekinumab and Placebo for Adalimumab in Crohn Disease, sponsored by Janssen Scientific Affairs, LLC. Completed at 182 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Janssen Scientific Affairs, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
386
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Read the detailed description

This study compares the safety and efficacy of ustekinumab versus adalimumab. It will consist of screening (within 1- 5 weeks prior to Week 0), treatment phase (Weeks 0 to 52), and follow-up phase (up to Week 76). The primary hypothesis is that ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy; CD-related healthcare utilization; patient-reported outcomes (PROs); laboratory evaluations; biomarkers; review of concomitant medications and adverse events (AEs); and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will randomly be assigned to receive either ustekinumab or adalimumab. No participants will be treated with placebo only.

02

Conditions studied

  • Crohn Disease

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
  • Has moderately-to-severely active CD with a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (\<=) 450
  • Has one or more ulceration on screening ileocolonoscopy (which by definition, would result in an Simple Endoscopic Score for Crohn's Disease [SES-CD] of at least 3)
  • Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine [AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is corticosteroid dependent
  • Has not previously received an approved biologic for Crohn's Disease (i.e., infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)
  • Participants on oral corticosteroids (e.g., prednisone, budesonide) at a prednisone-equivalent dose of \<=40 or milligram/day (mg/day) or \<=9 mg/day of budesonide are budesonide \<=9 mg/day are permitted if doses are stable for 3 weeks prior to baseline
  • Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue these medications at least 3 weeks prior to baseline

Exclusion criteria

Exclusion Criteria:

  • Has complications of CD that are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI, such as: active stoma; short-gut syndrome and severe or symptomatic strictures or stenosis
  • Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present
  • Has had any kind of bowel resection within 6 months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months prior to baseline
  • Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
  • Has received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or infected skin wounds or ulcers
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
386 participants (actual)

Study arms

  • Experimental
    Group 1 (Ustekinumab)

    Participants will receive intravenous (IV) infusion of ustekinumab (approximately 6 milligram/kilogram \[mg/kg\]) and 4 subcutaneous (SC) injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants will self-administer one SC injection of ustekinumab 90 milligram (mg) every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated every 2 weeks (q2w) dosing intervals.

    Biological: Placebo for Ustekinumab · Biological: Ustekinumab (6 mg/kg) · Biological: Ustekinumab (90 mg)

  • Active comparator
    Group 2 (Adalimumab)

    Participants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants will self-administer 1 SC injection of adalimumab 40 mg q2w.

    Biological: Placebo for Adalimumab · Biological: Adalimumab (40 mg)

Interventions

  • BiologicalPlacebo for Ustekinumab

    Participants will receive placebo as SC injection to blind adalimumab.

  • BiologicalPlacebo for Adalimumab

    Participants will receive placebo as IV infusion to blind ustekinumab.

  • BiologicalUstekinumab (6 mg/kg)

    Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.

    Also known as: Stelara

  • BiologicalUstekinumab (90 mg)

    Participants will self-administer SC injection of ustekinumab 90 mg.

    Also known as: Stelara

  • BiologicalAdalimumab (40 mg)

    Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.

    Also known as: Humira

05

What researchers measure

Primary outcomes

  1. Percentage of Participants With Clinical Remission at Week 52

    Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Week 52

Secondary outcomes

  1. Percentage of Participants With Corticosteroid-free Remission at Week 52

    Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score \<150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Week 52

  2. Percentage of Participants With Clinical Response at Week 52

    Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Week 52

  3. Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52

    PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP \<=1 and SF \<=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.

    Time frame: Week 52

  4. Percentage of Participants With Clinical Remission at Week 16

    Percentage of participants with clinical remission (defined as CDAI \<150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of \< 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Week 16

  5. Percentage of Participants With Endoscopic Remission at Week 52

    Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (\<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Time frame: Week 52

  6. Percentage of Participants With Clinical Remission Through Week 52

    Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  7. Percentage of Participants With Clinical Response Through Week 52

    Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of \>=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  8. Percentage of Participants With Durable Clinical Response at Week 52

    Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Week 52

  9. Percentage of Participants With Durable Clinical Remission at Week 52

    Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: Week 52

  10. Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52

    Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP\>0 at baseline, compared at each visit through Week 52.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  11. Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52

    Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number \<1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score \[ranges from 0 to 3 where higher score indicates severity of pain\] in the week prior to the visit) from baseline, among subjects with mean SF \>1 at baseline, compared at each visit through Week 52.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  12. Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52

    Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI \<150, CRP \<= 3 mg/L, and also fecal calprotectin \<=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Time frame: At Weeks 8, 16 and 52

  13. Percentage of Participants With Adverse Events (AEs)

    Percentage of participants with AE were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Time frame: Up to Week 52 and up to Week 76

  14. Percentage of Participants With Infections

    Percentage of participants with infections were reported.

    Time frame: Up to Week 52 and up to Week 76

  15. Percentage of Participants With Serious Infections

    Percentage of participants with serious infections were reported.

    Time frame: Up to Week 52 and up to Week 76

  16. Percentage of Participants With Serious Adverse Events (SAEs)

    Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms "COVID-19", "Asymptomatic COVID-19", "Suspected COVID-19", "COVID-19 pneumonia", "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive" or with a reported term containing the string "COVI.

    Time frame: Up to Week 52 and up to Week 76

  17. Percentage of Participants With Anti-drug Antibodies

    Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.

    Time frame: Up to Week 52

06

Results

Posted Jan 11, 2022

Participant flow

Participant flow — Overall Study
MilestoneAdalimumabUstekinumab
Started195191
Completed165166
Not completed3025
Withdrew: Lost to follow-up58
Withdrew: Withdrawal by subject1613
Withdrew: Death10
Withdrew: Other84

Outcome measures

PrimaryPercentage of Participants With Clinical Remission at Week 52

Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Remission at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Clinical Remission at Week 5261.064.9
SecondaryPercentage of Participants With Corticosteroid-free Remission at Week 52

Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score \<150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Corticosteroid-free Remission at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Corticosteroid-free Remission at Week 5257.460.7
SecondaryPercentage of Participants With Clinical Response at Week 52

Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Response at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Clinical Response at Week 5266.272.3
SecondaryPercentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP \<=1 and SF \<=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 5255.456.5
SecondaryPercentage of Participants With Clinical Remission at Week 16

Percentage of participants with clinical remission (defined as CDAI \<150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of \< 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Remission at Week 16
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Clinical Remission at Week 166057.1
SecondaryPercentage of Participants With Endoscopic Remission at Week 52

Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (\<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopic Remission at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Endoscopic Remission at Week 5230.728.5
SecondaryPercentage of Participants With Clinical Remission Through Week 52

Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Remission Through Week 52
percentage of participantsAdalimumabUstekinumab
Week 228.723.0
Week 847.750.3
Week 1660.057.1
Week 2466.257.6
Week 3265.159.7
Week 4060.564.9
Week 4859.062.8
Week 5261.064.9
SecondaryPercentage of Participants With Clinical Response Through Week 52

Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of \>=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Response Through Week 52
percentage of participantsAdalimumabUstekinumab
Week 246.238.2
Week 866.268.1
Week 1672.373.3
Week 2476.470.7
Week 3274.971.2
Week 4069.274.3
Week 4866.769.1
Week 5266.272.3
SecondaryPercentage of Participants With Durable Clinical Response at Week 52

Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Durable Clinical Response at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Durable Clinical Response at Week 5260.565.4
SecondaryPercentage of Participants With Durable Clinical Remission at Week 52

Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Durable Clinical Remission at Week 52
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Durable Clinical Remission at Week 5251.850.8
SecondaryPercentage of Participants With Abdominal Pain (AP) Improvement Through Week 52

Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP\>0 at baseline, compared at each visit through Week 52.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Reported as:
Number · percentage of participants
Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52
percentage of participantsAdalimumabUstekinumab
Week 229.923.0
Week 854.153.9
Week 1662.959.2
Week 2466.561.8
Week 3263.963.9
Week 4060.363.9
Week 4861.961.8
Week 5262.464.9
SecondaryPercentage of Participants With Reduction in Frequency of Diarrhea Through Week 52

Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number \<1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score \[ranges from 0 to 3 where higher score indicates severity of pain\] in the week prior to the visit) from baseline, among subjects with mean SF \>1 at baseline, compared at each visit through Week 52.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Reported as:
Number · percentage of participants
Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52
percentage of participantsAdalimumabUstekinumab
Week 233.330.7
Week 852.760.3
Week 1653.860.9
Week 2458.160.9
Week 3258.160.9
Week 4054.864.2
Week 4853.857.5
Week 5252.760.3
SecondaryPercentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52

Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI \<150, CRP \<= 3 mg/L, and also fecal calprotectin \<=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame:
At Weeks 8, 16 and 52
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52
percentage of participantsAdalimumabUstekinumab
Week 819.514.1
Week 1629.718.8
Week 5227.220.9
SecondaryPercentage of Participants With Adverse Events (AEs)

Percentage of participants with AE were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Time frame:
Up to Week 52 and up to Week 76
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events (AEs)
percentage of participantsAdalimumabUstekinumab
Up to Week 5277.980.1
Up to Week 7680.081.7
SecondaryPercentage of Participants With Infections

Percentage of participants with infections were reported.

Time frame:
Up to Week 52 and up to Week 76
Reported as:
Number · percentage of participants
Percentage of Participants With Infections
percentage of participantsAdalimumabUstekinumab
Up to Week 5240.534.0
Up to Week 7643.137.2
SecondaryPercentage of Participants With Serious Infections

Percentage of participants with serious infections were reported.

Time frame:
Up to Week 52 and up to Week 76
Reported as:
Number · percentage of participants
Percentage of Participants With Serious Infections
percentage of participantsAdalimumabUstekinumab
Up to Week 522.62.1
Up to Week 763.13.7
SecondaryPercentage of Participants With Serious Adverse Events (SAEs)

Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms "COVID-19", "Asymptomatic COVID-19", "Suspected COVID-19", "COVID-19 pneumonia", "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive" or with a reported term containing the string "COVI.

Time frame:
Up to Week 52 and up to Week 76
Reported as:
Number · percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs)
percentage of participantsAdalimumabUstekinumab
Up to Week 5216.413.1
Up to Week 52: COVID-19 related SAEs00
Up to Week 7619.515.2
Up to Week 76: COVID-19 related SAEs00.5
SecondaryPercentage of Participants With Anti-drug Antibodies

Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.

Time frame:
Up to Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Anti-drug Antibodies
percentage of participantsAdalimumabUstekinumab
Percentage of Participants With Anti-drug Antibodies74.42.1

Adverse events

Collected over Up to 81 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adalimumab1/195 (0.5%)38/195 (19.5%)151/195 (77.4%)
Ustekinumab0/191 (0%)29/191 (15.2%)152/191 (79.6%)
Most frequent serious events
Showing 10 of 49
Most frequent serious events
EventAdalimumabUstekinumab
Crohn's DiseaseGastrointestinal disorders17/1955/191
Small Intestinal ObstructionGastrointestinal disorders0/1953/191
Duodenal StenosisGastrointestinal disorders0/1952/191
Ileal StenosisGastrointestinal disorders1/1952/191
Intestinal ObstructionGastrointestinal disorders0/1952/191
AnaemiaBlood and lymphatic system disorders2/1951/191
PneumoniaInfections and infestations2/1951/191
Angina UnstableCardiac disorders0/1951/191
Venolymphatic MalformationCongenital, familial and genetic disorders0/1951/191
Abdominal PainGastrointestinal disorders0/1951/191
Most frequent other events
Showing 10 of 381
Most frequent other events
EventAdalimumabUstekinumab
Crohn's DiseaseGastrointestinal disorders29/19520/191
Abdominal PainGastrointestinal disorders16/19525/191
HeadacheNervous system disorders14/19525/191
NasopharyngitisInfections and infestations20/19514/191
Upper Respiratory Tract InfectionInfections and infestations15/19513/191
ArthralgiaMusculoskeletal and connective tissue disorders15/19513/191
Injection Site ErythemaGeneral disorders13/1953/191
NauseaGastrointestinal disorders9/19512/191
DiarrhoeaGastrointestinal disorders2/19511/191
VomitingGastrointestinal disorders4/19511/191

Baseline characteristics

Age, Continuous
Age, Continuous(years)AdalimumabUstekinumabTotal
Mean37.4 ± 12.9937 ± 13.2337.2 ± 13.09
Sex: Female, Male
Sex: Female, Male(Participants)AdalimumabUstekinumabTotal
Female100101201
Male9590185
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AdalimumabUstekinumabTotal
Hispanic or Latino141428
Not Hispanic or Latino178173351
Unknown or Not Reported347
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AdalimumabUstekinumabTotal
American Indian or Alaska Native000
Asian61117
Native Hawaiian or Other Pacific Islander000
Black or African American7815
White181164345
More than one race022
Unknown or Not Reported167
Region of Enrollment
Region of Enrollment(Participants)AdalimumabUstekinumabTotal
Australia527
Belgium235
Brazil91423
Bulgaria516
Canada7714
Czech Republic14822
France3811
Germany011
Hungary161329
Italy111021
Netherlands257
Poland342660
Republic of Korea3811
Russia272047
Serbia10212
Spain41418
United Kingdom121325
United States of America313667
07

Study locations

182 sites
  • Alabama Medical Group
    Mobile, Alabama 36608, United States
  • Precision Research Institute
    San Diego, California 92114, United States
  • Peak Gastroenterology Associates
    Colorado Springs, Colorado 80907, United States
  • Gastro Associates of Fairfield County PC
    Bridgeport, Connecticut 06606, United States
  • Western Connecticut Health Network/Danbury Hospital
    Danbury, Connecticut 06810, United States
  • Medstar Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Gastro Florida
    Clearwater, Florida 33756, United States
  • Florida Research Network, LLC
    Gainesville, Florida 32605, United States
  • Florida Center For Gastroenterology
    Largo, Florida 33777, United States
  • Center for Advanced Gastroenterology
    Maitland, Florida 32751, United States
  • Gastroenterology Group Of Naples
    Naples, Florida 34102, United States
  • Advanced Medical Research Center
    Port Orange, Florida 32127, United States
  • Apex Clinical Research
    Tampa, Florida 33612, United States
  • Cleveland Clinic Florida
    Weston, Florida 33331, United States
  • Atlanta Gastroenterology Specialists, PC
    Suwanee, Georgia 30024, United States
  • Grand Teton Research Group, PLLC
    Idaho Falls, Idaho 83404, United States
  • Health Science Research Center
    Pratt, Kansas 67124, United States
  • Tri-State Gastroenterology Assoc
    Crestview Hills, Kentucky 41017, United States
  • Gastroenterology Associates Of Hazard
    Hazard, Kentucky 41701, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Texas Digestive Disease Consultants
    Baton Rouge, Louisiana 70809, United States
  • CroNOLA, LLC
    Houma, Louisiana 70360, United States
  • Louisiana Research Center, LLC
    Shreveport, Louisiana 71105, United States
  • Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • Clinical Research Institute of Michigan, LLC
    Chesterfield, Michigan 48047, United States
  • Huron Gastroenterology Associates Center for Digestive Care
    Ypsilanti, Michigan 48197, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Saint Louis University Hospital
    Saint Louis, Missouri 63104, United States
  • Mercy Clinic East Community
    Saint Louis, Missouri 63141, United States
  • Saratoga Schenectady Gastroenterology Associates
    Burnt Hills, New York 12027, United States
  • NYU Langone Long Island Clinical Research Associates
    Great Neck, New York 11021, United States
  • Weill Cornell Medical College
    New York, New York 10021, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Premier Medical Group Of The Hudson Valley, Pc
    Poughkeepsie, New York 12601, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Digestive Health Partners
    Asheville, North Carolina 28801, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Duke University Hospital Medical Center
    Raleigh, North Carolina 27609, United States
  • Wilmington Gastroenterology Associates
    Wilmington, North Carolina 28403, United States
  • Fargo Gastroenterology Clinic, PC
    Fargo, North Dakota 58103, United States
  • Northshore Gastroenterology Research, LLC
    Beachwood, Ohio 44122, United States
  • TriHealth Digestive Institute
    Cincinnati, Ohio 45242, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Ohio State University Hospital
    Columbus, Ohio 43210, United States
  • Dayton Gastroenterology, Inc
    Dayton, Ohio 45440, United States
  • Great Lakes Gastroenterology Research, LLC
    Mentor, Ohio 44060, United States
  • Digestive Disease Specialists Inc
    Oklahoma City, Oklahoma 73112, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Allegheny-Singer Research Institute
    Pittsburgh, Pennsylvania 15212-4756, United States
  • Gastroenterology Associates P.A.
    Greenville, South Carolina 29615, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
  • Aztec Clinical Research, Inc.
    Channelview, Texas 77530, United States
  • DHAT Research Institute
    Garland, Texas 75044, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • University of Texas at Houston Medical School
    Houston, Texas 77030, United States
  • Gastroenterology Research of America, LLC
    San Antonio, Texas 78229, United States
  • Texas Digestive Disease Consultants
    Southlake, Texas 76092, United States
  • Tyler Research Institute, LLC
    Tyler, Texas 75701, United States
  • Gastroenterology Associates of Tidewater
    Chesapeake, Virginia 23320, United States
  • Verity Research, Inc
    Fairfax, Virginia 22031, United States
  • Gastroenterology Associates of Central Virginia
    Lynchburg, Virginia 24502, United States
  • Digestive And Liver Disease Specialists
    Norfolk, Virginia 23502, United States
  • McGuire VAMC
    Richmond, Virginia 23229, United States
  • Virginia Gastroenterology Institute
    Suffolk, Virginia 23434, United States
  • Washington Gastroenterology, PLLC
    Bellevue, Washington 98004, United States
  • Washington Gastroenterology, PLLC
    Tacoma, Washington 98405, United States
  • Monash Health, Monash Medical Centre
    Clayton, 3168, Australia
  • Alfred Hospital
    Melbourne, 3004, Australia
  • Mater Hospital Brisbane Inflammatory Bowel Diseases
    South Brisbane, 4101, Australia
  • St John of God Subiaco Hospital
    Subiaco, 6008, Australia
  • The Queen Elizabeth Hospital
    Woodville South, 5011, Australia
  • UZ Gent
    Gent, 9000, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • CHwapi
    Tournai, 7500, Belgium
  • Hospital Das Clinicas Da Ufmg
    Belo Horizonte - MG, 30130-100, Brazil
  • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
    Goiania, 74535-170, Brazil
  • Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida
    Juiz de Fora, 36033-318, Brazil
  • Hospital das Clinicas de Porto Alegre
    Porto Alegre, 90035-903, Brazil
  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
    Ribeirao Preto, 14098-900, Brazil
  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina
    Rio de Janeiro, 21941-590, Brazil
  • Hospital Copa D'Or
    Rio de Janeiro, CEP: 22031-010, Brazil
  • Fundacao do ABC Centro Universitario FMABC
    Santo Andre, 09060 870, Brazil
  • UMHAT 'Dr. Georgi Stranski', EAD
    Pleven, 5800, Bulgaria
  • MHAT Rousse
    Rousse, 7002, Bulgaria
  • 2-nd MHAT
    Sofia, 1202, Bulgaria
  • Diagnostic Consulting Center Mladost - M Varna
    Varna, 9020, Bulgaria
  • University of Calgary
    Calgary, Alberta T2N4Z6, Canada
  • McMaster University
    Hamilton, Ontario L8S 4K1, Canada
  • London Health Sciences Centre
    London, Ontario N6A 5A5, Canada
  • CISSS de la Monteregie Centre
    Greenfield Park, Quebec J4V 2H1, Canada
  • CMIIM, Centre médical L'Enjeu
    Mont-Royal, Quebec H7P 3E5, Canada
  • Fakultní nemocnice u sv. Anny v Brn
    Brno, 656 91, Czechia
  • Nemocnice Horovice, a.s.
    Horovice, 268 31, Czechia
  • Hepato-gastroenterologie HK, s.r.o.
    Hradec Kralove, 500 12, Czechia
  • Fakultni nemocnice Kralovske Vinohrady
    Praha 10, 100 34, Czechia
  • ISCARE a.s.
    Praha 9, 190 00, Czechia
  • CHU Amiens
    Amiens, 80054, France
  • CHRU Montpellier - Hopital Saint-Eloi
    Montpellier, 34295, France
  • Hotel Dieu
    Nantes, 44035, France

Showing the first 100 of 182 sites across 18 countries.

08

References and documents

Publications

  • Sands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2. PubMed 35691323 ↗

Study documents

  • Study protocol · Dec 14, 2020
  • Statistical analysis plan · Dec 16, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03464136
Lead sponsor
Janssen Scientific Affairs, LLC
Responsible party
Sponsor
First posted
Mar 13, 2018
Start date
Mar 29, 2018
Primary completion
Dec 15, 2020
Completion
May 21, 2021
Results posted
Jan 11, 2022
Last update
Apr 29, 2025

Study contacts

Janssen Scientific Affairs, LLC Clinical Trial
study director · Janssen Scientific Affairs, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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