Ulcerative ColitisPhase 2ExpeditionNCT03616821
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study testing Brazikumab in people with Ulcerative Colitis and IBD, run by AstraZeneca at 125 sites in 19 countries.
Trial summary
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, IBD
- What is being tested?
- Brazikumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 125 sitesin 19 countries
- Study dates
- 7 Aug 2018to 23 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Aged 18 to 80 years of age
- Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening
- Evidence of UC extending proximal to the rectum (≥ 15 cm of involved colon)
- Moderately to severely active UC as defined by:
- Average daily mMS Stool Frequency subscore ≥ 1 AND Average daily mMS Rectal Bleeding subscore ≥ 1
Show all 14Show fewer
- Modified Mayo endoscopic subscore of ≥ 2 based on a full colonoscopy within 14 days prior to randomization.
- Participant had an inadequate response or intolerance to intervention with conventional treatment or prior biological treatment or demonstrated CS dependence for the treatment of UC. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.
- Participants taking 5-aminosalicylates, oral prednisone (or equivalent), oral budesonide, or immunomodulators must be at a stable dose or discontinued. Topical (rectal) aminosalicylic acid or topical (rectal) steroids should be discontinued.
- Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control throughout the study and for at least 18 weeks after the last dose of study intervention.
- Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
- Non sterilized males who are sexually active with a female partner of childbearing potential should use condoms during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
- No known history of active TB or latent TB without completion of appropriate intervention and negative QFT-TB during Screening.
- Complete inclusion criteria are in the Clinical Study Protocol
Who cannot join
- Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
- Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded.
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
- Participant has received the following treatment:
- Infliximab: within 8 weeks prior to randomization.
- Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization.
Show all 39Show fewer
- Vedolizumab or ustekinumab within 12 weeks of randomization.
- Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to randomization.
- Fecal microbiota transplantation: within 8 weeks prior to randomization.
- Criterion deleted as part of Amendment 5 v6.0
- Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.
- Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy.
- Participant received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening.
- Participants who received IV or intramuscular steroids within 2 weeks prior to Screening.
- Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s), or receiving other investigational agent(s).
- Participant received a transfusion of blood, plasma, or platelets within 30 days prior to Screening.
- Participant received a Bacille Calmette-Guérin vaccination within 12 months of randomization or any other live vaccine less than 4 weeks prior to randomization.
- Participant has any of the following criteria related to infections:
- Evidence of a recent systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment.
- Any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of Screening.
- Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening.
- Clinically significant chronic infection that has not resolved within 8 weeks of Screening.
- Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with study medical monitor.
- Clinical evidence of or suspected to have an abscess during Screening.
- Any underlying condition that predisposes the participant to infections.
- Participant had previous allogenic bone marrow transplant or history of organ or cell-based transplantation.
- Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy.
- Signs or symptoms of ongoing infection due to intestinal pathogens.
- Participant has known or suspected history of chronic use of NSAIDs and/or opiates, drug, or alcohol abuse.
- History of cancer with the following exceptions: history of basal cell carcinoma and/or squamous cell carcinoma of the skin OR carcinoma in situ of the cervix; with apparent successful curative therapy, greater than 12 months prior to Screening.
- Clinically significant cardiovascular conditions.
- Prolonged QTcF interval or conditions leading to additional risk for QT prolongation.
- Clinically significant kidney disease
- Abnormal laboratory results at Screening as defined in the study protocol
- Participant is pregnant or breastfeeding or plans to become pregnant during the study.
- Participant has other known, pre-existing, clinically significant medical conditions that are not associated with UC and are uncontrolled with standard treatment.
- Participant has any disorder that may compromise the ability of the participant to give written informed consent and/or to comply with all required study procedures.
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Complete exclusion criteria are in the Clinical Study Protocol
Trial locations and contacts
125 sites in 19 countries.
125 sites in 19 countries
United States51 sites
Research Site
Amarillo, Texas, 79109
Research Site
Atlanta, Georgia, 30328
Research Site
Baton Rouge, Louisiana, 70809
Research Site
Beachwood, Ohio, 44122
Research Site
Biloxi, Mississippi, 39531
Research Site
Brownsburg, Indiana, 46112
Research Site
Carrollton, Texas, 75007
Research Site
Chula Vista, California, 91911
Research Site
Clearwater, Florida, 33756
Research Site
Colorado Springs, Colorado, 80907
Research Site
Evansville, Indiana, 47715
Research Site
Gurnee, Illinois, 60031
Research Site
Houston, Texas, 77017
Research Site
Houston, Texas, 77058
Research Site
Houston, Texas, 77598
Research Site
Humble, Texas, 77346
Research Site
Inverness, Florida, 34452
Research Site
Kissimmee, Florida, 34741
Research Site
Lakeland, Florida, 33813
Research Site
Lancaster, California, 93534
Research Site
Las Vegas, Nevada, 89106
Research Site
Las Vegas, Nevada, 89123
Research Site
Lincoln, California, 95648
Research Site
Little Rock, Arkansas, 72212
Research Site
Marrero, Louisiana, 70072
Research Site
Miami, Florida, 33157
Research Site
Miami, Florida, 33165
Research Site
Miami Lakes, Florida, 33016
Research Site
Mission Hills, California, 91345
Research Site
Morehead City, North Carolina, 28557
Research Site
Naples, Florida, 34102
Research Site
New Port Richey, Florida, 34653
Research Site
New York, New York, 10016
Research Site
North Chesterfield, Virginia, 23236
Research Site
Oak Lawn, Illinois, 60453
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Pflugerville, Texas, 78660
Research Site
Phoenix, Arizona, 85037
Research Site
Poway, California, 92064
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78258
Research Site
Shawnee Mission, Kansas, 66226
Research Site
Shreveport, Louisiana, 71105
Research Site
Springfield, Ohio, 45503
Research Site
Sunnyside, New York, 11104
Research Site
Tampa, Florida, 33614
Research Site
Tampa, Florida, 33626
Research Site
Topeka, Kansas, 66606
Research Site
Tucson, Arizona, 85712
Research Site
Uniontown, Pennsylvania, 15401
Research Site
Wyoming, Michigan, 49519
Japan14 sites
Research Site
Asahikawa-shi, 070-8610
Research Site
Chiba, 260-8677
Research Site
Fukuoka, 810-8563
Research Site
Fukuyama-shi
Research Site
Hakodate-shi, 040-8585
Research Site
Kasama-shi, 309-1793
Research Site
Kashiwa-shi, 277-0871
Research Site
Koshigaya-shi, 343-8555
Research Site
Kure-shi, 737-0023
Research Site
Minatoku, 108-8642
Research Site
Nagaoka-shi, 940-2085
Research Site
Onga-gun, 807-0051
Research Site
Sapporo, 064-0919
Research Site
Takarazuka-shi, 665-0827
Poland14 sites
Research Site
Bydgoszcz, 85-079
Research Site
Chojnice, 89-600
Research Site
Częstochowa, 42-202
Research Site
Gdansk, 80-382
Research Site
Krakow, 31-513
Research Site
Ksawerów, 95-054
Research Site
Piaseczno, 05-500
Research Site
Poznan, 60-702
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Rzeszów, 35-302
Research Site
Sopot, 81-756
Research Site
Torun, 87-100
Research Site
Warsaw, 00-189
Research Site
Warsaw, 03-580
Research Site
Wroclaw, 52-210
India6 sites
Research Site
Bangalore, 560054
Research Site
Hyderabad, 500032
Research Site
Jaipur, 302001
Research Site
New Delhi, 110075
Research Site
Rajkot, 360004
Research Site
Surat, 395002
Russia6 sites
Research Site
Aramil, 624002
Research Site
Izhevsk, 426035
Research Site
Moscow, 115419
Research Site
Novosibirsk, 630007
Research Site
Perm, 614000
Research Site
Tomsk, 634050
South Korea6 sites
Research Site
Busan, 48108
Research Site
Daegu, 42415
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Seoul, 06973
Research Site
Wŏnju, 26426
Czechia4 sites
Research Site
Brno, 636 00
Research Site
České Budějovice, 370 01
Research Site
Hradec Králové, 500 12
Research Site
Ostrava, 702 00
Italy4 sites
Research Site
Milan, 20132
Research Site
Negrar, 37024
Research Site
Rho, 20017
Research Site
Roma, 00168
South Africa4 sites
Research Site
Bloemfontein, 9301
Research Site
Cape Town, 7500
Research Site
Cape Town, 7708
Research Site
Plumstead, 7800
Germany3 sites
Research Site
Hamburg, 20251
Research Site
Kiel, 24105
Research Site
Ulm, 89081
Israel3 sites
Research Site
Haifa, 31096
Research Site
Jerusalem, 9103102
Research Site
Petah Tikva, 4941492
About this study
Official title: A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy
- Conditions
- Ulcerative Colitis, IBD
- Being tested
- Brazikumab, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrazikumabDrug
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
PlaceboDrug
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50.
| Study group | Role | What they receive |
|---|---|---|
| Brazikumab Dose 1 | Experimental | Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through week 50 Receives: Drug: Brazikumab |
| Brazikumab Dose 2 | Experimental | Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50 Receives: Drug: Brazikumab |
| Placebo | Placebo comparator | Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning on day 71 through Week 50. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
- stool frequency,
- rectal bleeding,
- endoscopic findings, and
- physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease).
Clinical Remission is defined by the mMS at Week 10:
- Endoscopy subscore = 0 or 1, AND
- Rectal bleeding subscore = 0, AND
- Stool frequency subscore = 0 or 1, AND at least a 1-point decrease from baseline
Further, if the patient
- discontinue treatment prematurely for any reason
- takes rescue treatment or meet the rescue criteria
- uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Measured: at Week 10
Secondary outcomes (21)
Sustained Clinical Remission
Sustained clinical remission defined as Modified Mayo Score (mMS): Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Further, if the patient
- discontinue treatment prematurely for any reason
- takes rescue treatment or meet the rescue criteria
- uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Measured: Week 10 and 54
CS-free Clinical Remission
CS-free clinical remission defined as mMS: Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Further, if the patient
- discontinue treatment prematurely for any reason
- takes rescue treatment or meet the rescue criteria
- uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Measured: Week 54
Clinical Response
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
- stool frequency,
- rectal bleeding,
- endoscopic findings, and
- physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
The Mayo score is the sum of the four subscores. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease).
Clinical response is defined as Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1
Further, if the patient
- discontinue treatment prematurely for any reason
- takes rescue treatment or meet the rescue criteria
- uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Measured: Week 10
Endoscopic Improvement
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
- stool frequency,
- rectal bleeding,
- endoscopic findings, and
- physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
Endoscopic improvement is defined as Endoscopy subscore ≤ 1.
Further, if the patient
- discontinue treatment prematurely for any reason
- takes rescue treatment or meet the rescue criteria
- uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Measured: Week 10
Serum Concentrations of Brazikumab (Induction)
Pharmacokinetics: concentration of brazikumab in serum
Measured: through week 10
Exposure-response
Participants with Clinical Remission by Quartile of Brazikumab concentration
Measured: through week 68
Incidence of Anti-drug Antibodies (Induction)
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Measured: through week 10
Adverse Events
Number and percentage of patients with reported adverse events.
Measured: Through week 68: Induction: AE with onset on or after first IV dose up to SC dose, or early term trt date + 18 wks after last dose. Maintenance: AE with onset on or after first SC dose up to and including 18 weeks after date of last SC dose.
Laboratory Values
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Measured: through week 68
Vital Signs
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Measured: through week 68
Abnormal ECG Results Through Week 68
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
Measured: through week 68
Serum Concentrations of Brazikumab (Maintenance)
Pharmacokinetics: concentration of brazikumab in serum
Measured: Week 30 through week 68
Incidence of Anti-drug Antibodies (Maintenance)
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Measured: Week 30 through week 68
mMS Total Score (Induction)
mMS total score at baseline and Week 10
Measured: through Week 10
mMS Component Score: Endoscopy (Induction)
Number of participants in each score category for Endoscopy score
Measured: through Week 10
mMS Component Score: Stool Frequency (Induction)
Number of participants in each score category for Stool frequency
Measured: through Week 10
mMS Component Score: Rectal Bleeding (Induction)
Number of participants in each score category for Rectal bleeding
Measured: through Week 10
Total mMS (Maintenance)
mMS total score at baseline and Week 54
Measured: Week 54
mMS Component Score: Endoscopy (Maintenance)
Number of participants in each score category for Endoscopy score
Measured: through Week 54
mMS Component Score: Stool Frequency (Maintenance)
Number of participants in each score category for Stool frequency score
Measured: through Week 54
mMS Component Score: Rectal Bleeding (Maintenance)
Number of participants in each score category for Rectal bleeding score
Measured: through Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start7 Aug 2018
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Why it stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Global, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Bohannon, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616821
- Sponsor's protocol ID
- D5272C00001
- Other IDs
- Legacy #3151-201-008, 2018-001605-93, 2018
- Acronym
- Expedition
- Status last verified
- May 2026
- First submitted
- 1 Aug 2018
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)
- ClinicalTrials.gov ID
- NCT03616821
- Acronym / sponsor ID
- Expedition / D5272C00001
- Conditions
- Ulcerative Colitis, IBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
- Enrolment
- 242 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Global, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Brazikumab Dose 1 | Experimental | Drug: BrazikumabIntravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through week 50 |
| Brazikumab Dose 2 | Experimental | Drug: BrazikumabIntravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50 |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning on day 71 through Week 50. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to provide informed consent
- Aged 18 to 80 years of age
- Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening
- Evidence of UC extending proximal to the rectum (≥ 15 cm of involved colon)
- Moderately to severely active UC as defined by:
Key exclusion criteria (39 listed)
- Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
- Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded.
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
- Participant has received the following treatment:
- Criterion deleted as part of Amendment 5 v6.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrazikumabIntravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50 | Drug | Brazikumab Dose 1, Brazikumab Dose 2 |
| PlaceboIntravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50. | Drug | Placebo |
Primary outcome
Clinical Remission
Time frame: at Week 10
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses * stool frequency, * rectal bleeding, * endoscopic findings, and * physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease). Clinical Remission is defined by the mMS at Week 10: * Endoscopy subscore = 0 or 1, AND * Rectal bleeding subscore = 0, AND * Stool frequency subscore = 0 or 1, AND at least a 1-point decrease from baseline Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
21 secondary outcomes
Sustained Clinical Remission
Time frame: Week 10 and 54
CS-free Clinical Remission
Time frame: Week 54
Clinical Response
Time frame: Week 10
Endoscopic Improvement
Time frame: Week 10
Serum Concentrations of Brazikumab (Induction)
Time frame: through week 10
Exposure-response
Time frame: through week 68
Incidence of Anti-drug Antibodies (Induction)
Time frame: through week 10
Adverse Events
Time frame: Through week 68: Induction: AE with onset on or after first IV dose up to SC dose, or early term trt date + 18 wks after last dose. Maintenance: AE with onset on or after first SC dose up to and including 18 weeks after date of last SC dose.
Laboratory Values
Time frame: through week 68
Vital Signs
Time frame: through week 68
Abnormal ECG Results Through Week 68
Time frame: through week 68
Serum Concentrations of Brazikumab (Maintenance)
Time frame: Week 30 through week 68
Incidence of Anti-drug Antibodies (Maintenance)
Time frame: Week 30 through week 68
mMS Total Score (Induction)
Time frame: through Week 10
mMS Component Score: Endoscopy (Induction)
Time frame: through Week 10
mMS Component Score: Stool Frequency (Induction)
Time frame: through Week 10
mMS Component Score: Rectal Bleeding (Induction)
Time frame: through Week 10
Total mMS (Maintenance)
Time frame: Week 54
mMS Component Score: Endoscopy (Maintenance)
Time frame: through Week 54
mMS Component Score: Stool Frequency (Maintenance)
Time frame: through Week 54
mMS Component Score: Rectal Bleeding (Maintenance)
Time frame: through Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CRS SynopsisLink provided by the sponsor.
- SAPLink provided by the sponsor.
- CSPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Bohannon study director
AstraZeneca
125 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brazikumab in people with Ulcerative Colitis and IBD, run by AstraZeneca at 125 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, Japan, Poland, India, Russia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission (time frame: at Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.