CompletedNCT01369342Updated Jan 6, 2017Results posted

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

A Phase 3 interventional study of Group 1: Placebo and Group 2 ustekinumab 130 mg in Crohn's Disease, Inflammatory Bowel Disease and IBD, sponsored by Janssen Research & Development, LLC. Completed at 220 sites in 22 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 640
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study summary

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

Read the detailed description

This study (CNTO1275CRD3002 or "UNITI-2") examines ustekinumab (an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical except without the ustekinumab antibody) given intravenously (by an IV) in adults with moderately to severely active Crohn's disease. Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab can provide benefit in Crohn's disease and also assess for any risks or side effects. Both the positive and negative outcomes of IV placebo versus two different doses of IV ustekinumab will be tracked and compared over eight weeks, in approximately 612 patients who have previously failed or were intolerant to corticosteroids or immunomodulators (methotrexate, azathioprine, or 6-mercaptopurine) or are dependent on corticosteroid medications. Patients enrolling in this study will be assigned to one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a single IV administration of study agent at the first study visit (after the screening period), and then will be asked to return for 3 additional visits through Week 8. Patients who complete this study through the Week 8 visit and remain eligible can enter the maintenance study (CNTO1275CRD3003 or "IM-UNITI"), where they will receive additional study agent, including the administration of ustekinumab in patients who receive placebo in this study and have not had improvement in their Crohn's disease. Patients who do not enter the CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after they received study agent when they entered into this study at the Week 0 visit. .All patients will receive a single intravenous (IV) administration of study drug (placebo or ustekinumab) at the start of the study.There are 3 treatment groups in this study: Group 1: Placebo; Group 2: ustekinumab 130 mg, Group 3: weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight > 55 kg and \<= 85 kg), and 520 mg (weight > 85 kg).

Conditions studied

Crohn's Disease
Inflammatory Bowel Disease
IBD
Colitis

Browse trials for

Keywords

ustekinumab
moderately to severely active Crohn's Disease
Stelara
IBD
colitis
crohn
UNITI
Crohn's

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's enrollment of 640 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.

Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and \<= 450, with confirmation of active inflammation
Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
Have screening laboratory test results within protocol-specified parameters

Exclusion criteria

Exclusion Criteria:

Patients who have had any kind of bowel resection within 6 months
Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
Patients who have received infliximab, adalimumab or certolizumab pegol \< = 8 weeks before the first administration of study drug
Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
Patients with a history of or ongoing chronic or recurrent infectious disease
Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 640 participants (actual)

Study arms

Placebo comparator
Placebo IV
Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
Drug: Group 1: Placebo
Experimental
Ustekinumab 130 milligram (mg)
Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
Drug: Group 2 ustekinumab 130 mg
Experimental
Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg)
Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg).
Drug: Group 3: ustekinumab approximately 6 mg/kg

Interventions

DrugGroup 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.
DrugGroup 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
DrugGroup 3: ustekinumab approximately 6 mg/kg
Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg).

What researchers measure

Primary outcomes

Number of Participants With Clinical Response at Week 6
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Time frame: Week 6

Secondary outcomes

Number of Participants in Clinical Remission at Week 8
Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points.
Time frame: Week 8
Number of Participants in Clinical Response at Week 8
Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Time frame: Week 8
Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6
70-point response is defined as at least 70 points reduction in CDAI score (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 6
Number of Participants With CDAI 70 Point Response at Week 3
70-point response is defined as at least 70 points reduction in CDAI score (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 3

Results

Posted Jan 6, 2017

Limitations and caveats

The global study was interrupted due to issues with the clinical supply.

Participant flow

A total of 640 participants were randomly assigned to receive study agent. The analyses (efficacy) were based on the 628 participants who were randomized after the study was restarted. However, one additional participant was excluded from efficacy analyses due to misconduct by the investigative site.

Participant flow — Overall Study
Milestone	Placebo IV	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Started	214	213	213
Completed	201	204	210
Not completed	13	9	3
Withdrew: Withdrawal by subject	7	7	2
Withdrew: Lost to follow-up	5	2	1
Withdrew: Not treated	1	0	0

Outcome measures

PrimaryNumber of Participants With Clinical Response at Week 6

Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.

Time frame:: Week 6
Reported as:: Number · participants

Number of Participants With Clinical Response at Week 6
participants	Placebo	Ustekinumab 130 mg	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Number of Participants With Clinical Response at Week 6	60	108	116

Statistical analysis

Placebo vs Ustekinumab 130 mg · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).
Placebo vs Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).

SecondaryNumber of Participants in Clinical Remission at Week 8

Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points.

Time frame:: Week 8
Reported as:: Number · participants

Number of Participants in Clinical Remission at Week 8
participants	Placebo	Ustekinumab 130 mg	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Number of Participants in Clinical Remission at Week 8	41	64	84

Statistical analysis

Placebo vs Ustekinumab 130 mg · Cochran-Mantel-Haenszel chi-square test · p = 0.009 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).
Placebo vs Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).

SecondaryNumber of Participants in Clinical Response at Week 8

Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.

Time frame:: Week 8
Reported as:: Number · participants

Number of Participants in Clinical Response at Week 8
participants	Placebo	Ustekinumab 130 mg	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Number of Participants in Clinical Response at Week 8	67	99	121

Statistical analysis

Placebo vs Ustekinumab 130 mg · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).
Placebo vs Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).

SecondaryNumber of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6

70-point response is defined as at least 70 points reduction in CDAI score (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 6
Reported as:: Number · participants

Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6
participants	Placebo	Ustekinumab 130 mg	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6	81	123	135

Statistical analysis

Placebo vs Ustekinumab 130 mg · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).
Placebo vs Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).

SecondaryNumber of Participants With CDAI 70 Point Response at Week 3

Time frame:: Week 3
Reported as:: Number · participants

Number of Participants With CDAI 70 Point Response at Week 3
participants	Placebo	Ustekinumab 130 mg	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Number of Participants With CDAI 70 Point Response at Week 3	66	103	106

Statistical analysis

Placebo vs Ustekinumab 130 mg · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).
Placebo vs Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) · Cochran-Mantel-Haenszel chi-square test · p = < 0.001 (A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.)2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).

Adverse events

Collected over Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo IV	—	15/212 (7.1%)	44/212 (20.8%)
Ustekinumab 130 Milligram (mg)	—	10/216 (4.6%)	40/216 (18.5%)
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	—	9/211 (4.3%)	44/211 (20.9%)

Most frequent serious events

Showing 10 of 23

Most frequent serious events
Event	Placebo IV	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Crohn's DiseaseGastrointestinal disorders	5/212	5/216	2/211
Anal AbscessInfections and infestations	3/212	2/216	0/211
Small Intestinal ObstructionGastrointestinal disorders	1/212	1/216	2/211
ColitisGastrointestinal disorders	0/212	0/216	1/211
Chest PainGeneral disorders	0/212	0/216	1/211
GastroenteritisInfections and infestations	0/212	0/216	1/211
Pneumothorax SpontaneousRespiratory, thoracic and mediastinal disorders	0/212	1/216	1/211
Pulmonary GranulomaRespiratory, thoracic and mediastinal disorders	0/212	0/216	1/211
AnaemiaBlood and lymphatic system disorders	1/212	1/216	0/211
PancytopeniaBlood and lymphatic system disorders	1/212	0/216	0/211

Most frequent other events

Most frequent other events
Event	Placebo IV	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
HeadacheNervous system disorders	14/212	20/216	10/211
NasopharyngitisInfections and infestations	10/212	10/216	14/211
NauseaGastrointestinal disorders	5/212	7/216	11/211
PyrexiaGeneral disorders	10/212	6/216	11/211
Upper Respiratory Tract InfectionInfections and infestations	11/212	4/216	7/211

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo IV	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Total
Mean	40.1 ± 13.09	39.2 ± 13.74	38.8 ± 13.65	39.4 ± 13.48

Gender
Gender(Participants)	Placebo IV	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Total
Female	113	107	122	342
Male	101	106	91	298

Region of Enrollment
Region of Enrollment(participants)	Placebo IV	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Total
Australia	8	7	5	20
Belgium	1	1	2	4
Bulgaria	8	5	11	24
Brazil	2	5	2	9
Canada	14	18	10	42
Germany	19	15	13	47
Spain	0	1	0	1
France	3	2	5	10
United Kingdom	8	8	5	21
Croatia	1	2	1	4
Hungary	23	20	18	61
Iceland	0	1	1	2
Israel	2	3	6	11
Italy	2	2	5	9
Japan	9	8	9	26
Korea	7	7	6	20
Netherland	1	1	2	4
New Zealand	2	8	4	14
Poland	8	8	10	26
Russia	6	6	5	17
Serbia	4	8	3	15
United States	72	72	76	220
South Africa	14	5	14	33

Study locations

220 sites

Tucson, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Los Angeles, California, United States
San Diego, California, United States
Santa Monica, California, United States
Torrance, California, United States
Lone Tree, Colorado, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Port Orange, Florida, United States
Winter Park, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Clive, Iowa, United States
Pratt, Kansas, United States
Topeka, Kansas, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Houma, Louisiana, United States
New Orleans, Louisiana, United States
Chevy Chase, Maryland, United States
Columbia, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Novi, Michigan, United States
Troy, Michigan, United States
Ypsilanti, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
Ocean Springs, Mississippi, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Lees Summit, Missouri, United States
Urbana, Missouri, United States
Las Vegas, Nevada, United States
Egg Harbor, New Jersey, United States
Marlton, New Jersey, United States
Morristown, New Jersey, United States
Great Neck, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Beavercreek, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Mentor, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Portland, Oregon, United States
Malvern, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
North Charleston, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Virginia Beach, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Adelaide, Australia
Cairns, Australia
Central Queensland M C, Australia
Concord, Australia
Fremantle, Australia
Garran, Australia
Liverpool, Australia
Malvern, Australia
Parkville, Australia
Brussels, Belgium
Leuven, Belgium
Goiânia, Brazil
Porto Alegre, Brazil
Rio de Janeiro, Brazil
São Paulo, Brazil
Pleven, Bulgaria

Showing the first 100 of 220 sites across 22 countries.

References and documents

Publications

Ye BD, Sugimoto K, Cheon JH, Gasink C, Imai Y, Wahking B, Zhuo J, Kawamura S, Hibi T. Efficacy and safety of ustekinumab in Asian patients with moderately to severely active Crohn's disease: a small subpopulation analysis of UNITI/IM-UNITI long-term extension through 5 years. Intest Res. 2026 Jul 10. doi: 10.5217/ir.2025.00285. Online ahead of print. PubMed 42427284 ↗
Ghosh S, Feagan BG, Ott E, Gasink C, Godwin B, Marano C, Miao Y, Ma T, Loftus EV Jr, Sandborn WJ, Danese S, Abreu MT, Sands BE. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis. J Crohns Colitis. 2024 Aug 6;18(7):1091-1101. doi: 10.1093/ecco-jcc/jjae013. PubMed 38310565 ↗
Colombel JF, Sands BE, Gasink C, Yeager B, Adedokun OJ, Izanec J, Ma T, Gao LL, Lee SD, Targan SR, Ghosh S, Hanauer SB, Sandborn WJ. Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2024 Jan;22(1):144-153.e2. doi: 10.1016/j.cgh.2023.06.014. Epub 2023 Jun 28. PubMed 37391056 ↗
Dubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27. PubMed 37368103 ↗
Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21. PubMed 36150926 ↗
Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2. PubMed 34077627 ↗
Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. PubMed 32964215 ↗
Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4. PubMed 31279870 ↗
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. PubMed 30739254 ↗
Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29. PubMed 29909019 ↗
Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1. PubMed 29409871 ↗
Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23. PubMed 29142515 ↗
Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960. doi: 10.1056/NEJMoa1602773. PubMed 27959607 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Aug 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2017, 2 years 5 months after primary completion. A results delay was requested in Jul 2015.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 7, 2011
First posted: Jun 8, 2011
Start: Jul 2011
Primary completionActual: Aug 2014
CompletionActual: Oct 2014
Results delay requested: Jul 2, 2015
Results first posted: Jan 6, 2017
Last update: Jan 6, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01369342
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Jun 8, 2011
Start date: Jul 2011
Primary completion: Aug 2014
Completion: Oct 2014
Results posted: Jan 6, 2017
Last update: Jan 6, 2017

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

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