CompletedNCT03662542VEGAUpdated Dec 12, 2023Results posted

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2 interventional study of Guselkumab Dose 1 and Guselkumab Dose 2 in Colitis, Ulcerative, sponsored by Janssen Research & Development, LLC. Completed at 82 sites in 9 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 214
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Conditions studied

Colitis, Ulcerative

Browse trials for

Colitis, Ulcerative 1,530

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's enrollment of 214 is above the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative 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 65 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

Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
Moderately to severely active UC as defined by Mayo score
History of inadequate response to or failure to tolerate conventional therapy
Has screening laboratory test results within the study protocol defined parameters
A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0

Exclusion criteria

Exclusion Criteria:

Has severe extensive colitis as defined in the study protocol
Has UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 214 participants (actual)

Study arms

Experimental
Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Drug: Guselkumab Dose 1 · Drug: Guselkumab Dose 2 · Drug: Golimumab Dose 1 · Drug: Golimumab Dose 2 · Drug: Placebo
Experimental
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Drug: Guselkumab Dose 1 · Drug: Guselkumab Dose 2 · Drug: Placebo
Active comparator
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Drug: Golimumab Dose 1 · Drug: Golimumab Dose 2 · Drug: Placebo

Interventions

DrugGuselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion.
DrugGuselkumab Dose 2
Guselkumab Dose 2 will be administered as SC injection.
DrugGolimumab Dose 1
Golimumab Dose 1 will be administered as SC injection.
DrugGolimumab Dose 2
Golimumab Dose 2 will be administered as SC injection.
DrugPlacebo
Placebo will be administered.

What researchers measure

Primary outcomes

Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Time frame: Week 12

Secondary outcomes

Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
Clinical remission was defined as the Mayo score less than or equal to (\<=) 2 with no individual subscore greater than (\>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Time frame: Week 12

Results

Posted Dec 12, 2023

Participant flow

Combination Phase ( Week 0- Week 12)

Participant flow — Combination Phase ( Week 0- Week 12)
Milestone	Combination Phase: Golimumab Monotherapy	Combination Phase: Guselkumab Monotherapy	Combination Phase: Combination Therapy
Started	72	71	71
Completed	67	70	71
Not completed	5	1	0
Withdrew: Withdrawal by subject	3	0	0
Withdrew: Adverse event	0	1	0
Withdrew: Other	1	0	0
Withdrew: Covid-19	1	0	0

Monotherapy Phase (Week 12-Week 38)

Participant flow — Monotherapy Phase (Week 12-Week 38)
Milestone	Monotherapy Phase: Golimumab Monotherapy	Monotherapy Phase: Guselkumab Monotherapy	Monotherapy Phase: Combination Therapy
Started	67	70	71
Completed	62	67	65
Not completed	5	3	6
Withdrew: Death	0	0	1
Withdrew: Lost to follow-up	1	1	0
Withdrew: Withdrawal by subject	4	1	1
Withdrew: Other	0	1	2
Withdrew: Adverse event	0	0	2

Safety Follow-up (Week 38- Week 50)

Participant flow — Safety Follow-up (Week 38- Week 50)
Milestone	Safety Follow-up: Golimumab Monotherapy	Safety Follow-up: Guselkumab Monotherapy	Safety Follow-up: Combination Therapy
Started	58	65	60
Completed	55	58	55
Not completed	3	7	5
Withdrew: Death	0	1	0
Withdrew: Lost to follow-up	1	0	1
Withdrew: Withdrawal by subject	1	0	2
Withdrew: Other	1	6	2

Outcome measures

PrimaryCombination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12

Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.

Time frame:: Week 12
Reported as:: Number · Percentage of participants

Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Percentage of participants	Combination Phase: Golimumab Monotherapy	Combination Phase: Guselkumab Monotherapy	Combination Phase: Combination Therapy
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12	61.1	74.6	83.1

SecondaryCombination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12

Clinical remission was defined as the Mayo score less than or equal to (\<=) 2 with no individual subscore greater than (\>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.

Time frame:: Week 12
Reported as:: Number · Percentage of participants

Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
Percentage of participants	Combination Phase: Golimumab Monotherapy	Combination Phase: Guselkumab Monotherapy	Combination Phase: Combination Therapy
Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12	22.2	21.1	36.6

Adverse events

Collected over Up to Week 50. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Combination Phase: Golimumab Monotherapy	0/72 (0%)	1/72 (1.4%)	19/72 (26.4%)
Combination Phase: Guselkumab Monotherapy	0/71 (0%)	2/71 (2.8%)	16/71 (22.5%)
Combination Phase: Combination Therapy	0/71 (0%)	1/71 (1.4%)	14/71 (19.7%)
Monotherapy Phase: Golimumab Monotherapy	0/67 (0%)	3/67 (4.5%)	12/67 (17.9%)
Monotherapy Phase: Guselkumab Monotherapy	0/70 (0%)	1/70 (1.4%)	16/70 (22.9%)
Monotherapy Phase: Combination Therapy	1/71 (1.4%)	3/71 (4.2%)	14/71 (19.7%)
Safety Follow-up: Golimumab Monotherapy	0/58 (0%)	0/58 (0%)	3/58 (5.2%)
Safety Follow-up: Guselkumab Monotherapy	1/65 (1.5%)	2/65 (3.1%)	2/65 (3.1%)
Safety Follow-up: Combination Therapy	0/60 (0%)	0/60 (0%)	0/60 (0%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Combination Phase: Golimumab Monotherapy	Combination Phase: Guselkumab Monotherapy	Combination Phase: Combination Therapy	Monotherapy Phase: Golimumab Monotherapy	Monotherapy Phase: Guselkumab Monotherapy	Monotherapy Phase: Combination Therapy	Safety Follow-up: Golimumab Monotherapy	Safety Follow-up: Guselkumab Monotherapy	Safety Follow-up: Combination Therapy
Gastrointestinal HaemorrhageGastrointestinal disorders	0/72	0/71	0/71	0/67	0/70	0/71	0/58	1/65	0/60
Covid-19Infections and infestations	0/72	0/71	0/71	0/67	0/70	0/71	0/58	1/65	0/60
Adenocarcinoma of ColonNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/72	0/71	0/71	0/67	0/70	0/71	0/58	1/65	0/60
Chronic SinusitisInfections and infestations	0/72	0/71	0/71	1/67	0/70	0/71	0/58	0/65	0/60
Covid-19 PneumoniaInfections and infestations	0/72	0/71	0/71	1/67	0/70	0/71	0/58	0/65	0/60
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders	0/72	0/71	0/71	1/67	0/70	1/71	0/58	0/65	0/60
BronchitisInfections and infestations	0/72	0/71	0/71	0/67	1/70	0/71	0/58	0/65	0/60
Atrial FibrillationCardiac disorders	0/72	1/71	0/71	0/67	0/70	0/71	0/58	0/65	0/60
Small Intestinal ObstructionGastrointestinal disorders	0/72	1/71	0/71	0/67	0/70	0/71	0/58	0/65	0/60
InfluenzaInfections and infestations	0/72	0/71	1/71	0/67	0/70	0/71	0/58	0/65	0/60

Most frequent other events

Most frequent other events
Event	Combination Phase: Golimumab Monotherapy	Combination Phase: Guselkumab Monotherapy	Combination Phase: Combination Therapy	Monotherapy Phase: Golimumab Monotherapy	Monotherapy Phase: Guselkumab Monotherapy	Monotherapy Phase: Combination Therapy	Safety Follow-up: Golimumab Monotherapy	Safety Follow-up: Guselkumab Monotherapy	Safety Follow-up: Combination Therapy
Colitis UlcerativeGastrointestinal disorders	8/72	1/71	4/71	5/67	4/70	6/71	3/58	1/65	0/60
AnaemiaBlood and lymphatic system disorders	5/72	6/71	4/71	2/67	6/70	0/71	0/58	1/65	0/60
Upper Respiratory Tract InfectionInfections and infestations	4/72	5/71	1/71	2/67	2/70	6/71	0/58	0/65	0/60
HeadacheNervous system disorders	2/72	3/71	4/71	2/67	5/70	3/71	0/58	0/65	0/60
NeutropeniaBlood and lymphatic system disorders	2/72	4/71	2/71	1/67	2/70	2/71	0/58	0/65	0/60

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Golimumab Monotherapy	Guselkumab Monotherapy	Combination Therapy	Total
<=18 years	0	0	0	0
Between 18 and 65 years	72	70	71	213
>=65 years	0	1	0	1

Age, Continuous
Age, Continuous(years)	Golimumab Monotherapy	Guselkumab Monotherapy	Combination Therapy	Total
Mean	38.1 ± 10.47	39.1 ± 13.67	37.8 ± 11.69	38.4 ± 11.96

Sex: Female, Male
Sex: Female, Male(Participants)	Golimumab Monotherapy	Guselkumab Monotherapy	Combination Therapy	Total
Female	30	31	37	98
Male	42	40	34	116

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Golimumab Monotherapy	Guselkumab Monotherapy	Combination Therapy	Total
Hispanic or Latino	4	6	5	15
Not Hispanic or Latino	68	65	66	199
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Golimumab Monotherapy	Guselkumab Monotherapy	Combination Therapy	Total
American Indian or Alaska Native	2	0	0	2
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	3	0	1	4
White	67	71	70	208
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Golimumab Monotherapy	Guselkumab Monotherapy	Combination Therapy	Total
ARGENTINA	0	1	3	4
AUSTRALIA	2	1	1	4
BRAZIL	2	3	4	9
GERMANY	0	1	1	2
MEXICO	2	2	0	4
POLAND	15	11	14	40
RUSSIAN FEDERATION	19	22	30	71
UKRAINE	27	25	16	68
UNITED STATES	5	5	2	12

Study locations

82 sites

Precision Research Institute
San Diego, California 92114, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907, United States
GCP Clinical Research
Tampa, Florida 33609, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060, United States
Indiana University
Indianapolis, Indiana 46202, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815, United States
Woodholme Gastroenterology
Glen Burnie, Maryland 21061, United States
Sierra Clinical Research
Las Vegas, Nevada 89106, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599, United States
Fargo Gastroenterology Clinic, PC
Fargo, North Dakota 58103, United States
Texas Digestive Disease Consultants
Southlake, Texas 76092, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320, United States
Virginia Mason
Seattle, Washington 98101, United States
Washington Gastroenterology, PLLC
Tacoma, Washington 98405, United States
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires, 1431, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
Expertia S.A
Caba, C1128AAF, Argentina
Centro Médico Dra. De Salvo
Caba, C1426ABP, Argentina
Clínica Adventista Belgrano
Ciudad de Buenos Aires, C1430EGF, Argentina
Fundacion de Estudios Clinicos
Rosario, 2000, Argentina
Hospital de Alta Complejidad en Red 'El Cruce'
San Juan Bautista, 1888, Argentina
Sanatorio 9 de Julio
San Miguel de Tucumán, 4000, Argentina
Princess Alexandra Hospital
Brisbane, 4102, Australia
St Vincent's Hospital - Melbourne
Fitzroy, 3065, Australia
Nepean Hospital
Kingswood, 2747, Australia
Royal Adelaide Hospital
North Terrace, 5000, Australia
Macquarie University Hospital
NSW, 2109, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
Mater Hospital Brisbane (Inflammatory Bowel Diseases)
South Brisbane, 4101, Australia
Hospital Das Clinicas Da Ufmg
Belo Horizonte, 30130-100, Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, 18618-970, Brazil
Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
Goiânia, 74535-170, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirão Preto, 14098-900, Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro, 20050-902, Brazil
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180, Brazil
Fundacao do ABC - Centro Universitario FMABC
Santo André, 09060-870, Brazil
Kaiser Hospta
São José do Rio Preto, 15015-110, Brazil
Eurolatino Pesquisas Medicas Ltda
Uberlândia, 38400-368, Brazil
Charite Berlin
Berlin, 12203, Germany
Universitatsklinikum Frankfurt/ Medizinische Klinik 1
Frankfurt, 60590, Germany
Universitätsklinikum Jena
Jena, 07740, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Clínica Saluz
Boca del Rio, 94229, Mexico
Clinicos Asociados BOCM, SC
Mexico City, 03300, Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, 64610, Mexico
Capital Humano para la Investigacion clinica
Querétaro, 76000, Mexico
Centro Medico Zambrano Hellion
San Pedro Garza García, 66278, Mexico
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382, Poland
Pratia MCM Krakow
Krakow, 30-510, Poland
Endoskopia Sp. z o.o. z siedzibą w Sopocie
Sopot, 81-756, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507, Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warsaw, 03 580, Poland
Melita Medical Sp. z o.o.
Wroclaw, 50-449, Poland
Kazan State Medical University
Kazan', 420012, Russia
City Clinical Hospital # 24
Moscow, 127015, Russia
Medical Center SibNovoMed LLC
Novosibirsk, 630005, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
International Medical Centre SOGAZ
Saint Petersburg, 191186, Russia
Elizavetinskaya hospital
Saint Petersburg, 195257, Russia
Eco-safety Ltd
Saint Petersburg, 196143, Russia
City Clinical Hospital #31
Saint Petersburg, 197110, Russia
Medical University Reaviz
Samara, 443001, Russia
Tver Regional Clinical Hospital
Tver', 170036, Russia
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
Ufa, 450005, Russia
City Clinical Hospital #2
Yaroslavl, 150010, Russia
Regional Clinical Hospital
Yaroslavl, 150062, Russia
Medical Association 'New Hospital'
Yekaterinburg, 620109, Russia
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
Kharkiv, 61037, Ukraine
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
Kharkiv, 61039, Ukraine
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
Kherson, 73003, Ukraine
Kyiv City Clinical Hospital #18
Kyiv, 01030, Ukraine
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
Kyiv, 02091, Ukraine
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
Lviv, 79007, Ukraine
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010, Ukraine
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odesa, 65025, Ukraine
Sumy State University, Sumy Regional Clinical Hospital
Sumy, 40022, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, 46002, Ukraine
Medical Center Ltd 'Health Clinic', Department Of General Therapy
Vinnytsia, 21009, Ukraine
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Vinnytsia, 21018, Ukraine

References and documents

Publications

Shao J, Vetter M, Vermeulen A, Feagan BG, Sands BE, Panes J, Xu Z. Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions. Clin Pharmacol Ther. 2024 Jun;115(6):1418-1427. doi: 10.1002/cpt.3235. Epub 2024 Mar 15. PubMed 38488354 ↗
Feagan BG, Sands BE, Sandborn WJ, Germinaro M, Vetter M, Shao J, Sheng S, Johanns J, Panes J; VEGA Study Group. Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):307-320. doi: 10.1016/S2468-1253(22)00427-7. Epub 2023 Feb 1. PubMed 36738762 ↗

Study documents

Study protocol · Mar 7, 2019
Statistical analysis plan · Feb 24, 2021

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

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Dec 2020, 24 months.

Results were first posted in Dec 2023, 3 years after primary completion. A results delay was requested in Nov 2021.

Of 104 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's 24 months is below that.

Counting every sponsor, half of 142 studies reached it within 28 months; a quarter within 23 and three quarters within 42.

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

Registered: Sep 6, 2018
First posted: Sep 7, 2018
StartActual: Nov 20, 2018
Primary completionActual: Dec 1, 2020
CompletionActual: Nov 15, 2021
Results delay requested: Nov 26, 2021
Results first posted: Dec 12, 2023
Last update: Dec 12, 2023

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 Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03662542
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Sep 7, 2018
Start date: Nov 20, 2018
Primary completion: Dec 1, 2020
Completion: Nov 15, 2021
Results posted: Dec 12, 2023
Last update: Dec 12, 2023

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Guselkumab

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