Crohn's DiseasePhase 3INTREPID OLENCT03961815

Open-label Extension Study of Brazikumab in Crohn's Disease

A Phase 3 study testing Brazikumab Induction Dose and Brazikumab Maintenance Dose in people with Crohn's Disease and IBD, run by AstraZeneca at 15 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Crohn's Disease, IBD
What is being tested?: Brazikumab Induction Dose and Brazikumab Maintenance Dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 15 sitesin 5 countries
Study dates: 6 Jan 2020to 19 Sep 2023
Phase: Phase 3
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

Male or female participants with successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008).
Meets 1 of the following criteria for successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008):
A participant is considered to have completed the D5271C00001 (Legacy #3150-301-008) study if they have received scheduled study interventions, completed scheduled visits, and completed Week 52 assessments.
A participant in Study D5271C00001 (Legacy #3150-301-008) who discontinued from the study due to lack of efficacy after a minimum of 12 weeks of double-blind treatment and met criteria for the use of rescue treatment in the lead-in protocol.
Criterion deleted as part of Amendment.
Each participant must have had the ileocolonoscopic procedure at the final visit (Week 52, Week 12, or early termination after Week 12 of Study D5271C00001 (Legacy # 3150-301-008).

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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 (confirmed by the investigator) from signing the ICF throughout the study duration and for at least 18 weeks after 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. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to signing the ICF without an alternative medical cause.
Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Written informed consent from the participant has been obtained prior to any study related procedures.
Legally authorized representative consent has been obtained (if applicable).
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
Demonstration of adequate compliance with the study procedures in Study D5271C00001 (Legacy #3150 301-008) in the opinion of the investigator and/or sponsor.
Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study.
Complete inclusion criteria are in the study protocol

Who cannot join

Any participant with an unresolved AE from the Study D5271C00001 (Legacy #3150 301-008) that would limit the participant's ability to participate in or complete this study.
Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primary sclerosing cholangitis.
Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
Any other condition or finding that, in the investigator's or sponsor's opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk.
History of cancer except for basal cell and/or squamous cell carcinoma of the skin, and carcinoma in situ of the cervix within 12 months of screening.
Participant meets criteria for discontinuation of study intervention during prior the D5271C00001 (Legacy #3150 301-008) study (excluding lack of efficacy).

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Criterion deleted as part of Amendment.
Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection.
Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branch block; determined by central ECG), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome).
Clinically significant kidney disease including but not limited to:
Chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml/min calculated by MDRD equation, as applicable, by the central laboratory at screening are excluded.
Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment, or prohibited treatment.
Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 (Visit 1) or any other live vaccine < 4 weeks prior to Week 0 (Visit 1) or is planning to receive any such vaccine over the course of the study.
Participant received a prohibited medication during participation in the lead-in study or during screening for this study.
Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5271C00002 (Legacy #3150-303-008) with the exception of "registry" or "cohort" trials.
Participants with a known hypersensitivity to brazikumab or any of the excipients of the product.
Protocol-defined abnormal laboratory results at screening. 17. Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly.
18 Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of AstraZeneca, or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site.
19 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
20 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
21 Previous participation in the present study.
Complete exclusion criteria are in the study protocol

Trial locations and contacts

15 sites in 5 countries.

Country

City, postcode or hospital

15 sites in 5 countries

United States10 sites

Research Site
Beachwood, Ohio, 44122
Research Site
Clearwater, Florida, 33756
Research Site
Houston, Texas, 77058
Research Site
Kissimmee, Florida, 34741
Research Site
Lakeland, Florida, 33813
Research Site
Lincoln, California, 95648
Research Site
Miami, Florida, 33157
Research Site
Miami, Florida, 33165
Research Site
Miami Lakes, Florida, 33016
Research Site
Tampa, Florida, 33626

Other trials in United States

South Africa2 sites

Research Site
Cape Town, 7500
Research Site
Plumstead, 7800

Other trials in South Africa

Germany1 site

Research Site
Hamburg, 20251

Other trials in Germany

Poland1 site

Research Site
Rzeszów, 35-302

Other trials in Poland

Taiwan1 site

Research Site
Taichung, 40443

Other trials in Taiwan

About this study

Official title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)

Conditions: Crohn's Disease, IBD
Being tested: Brazikumab Induction Dose, Brazikumab Maintenance Dose
Keywords: Crohn's Disease, Inflammatory bowel disease, Brazikumab, IL23 receptor, IBD, CD
Medical subject headings: Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brazikumab Induction DoseDrug
Participants who met criteria for early termination due to lack of efficacy (rescue treatment criteria) or who did not meet CDAI response at Week 52 in the lead-in study D5121C00001 are considered inadequate/non responders, and will receive IV induction dosing brazikumab at Week 0, Week 4, and Week 8 followed by maintenance dosing of brazikumab subcutaneously every 4 weeks thereafter up to Week 52.
Brazikumab Maintenance DoseDrug
Responders from Lead-In study D5271C00001 who completed requirements through Week 52 and met CDAI response (CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points) without ongoing rescue treatment at Week 52 in the lead-in study. will receive maintenance dose of brazikumab administered subcutaneously every 4 weeks through Week 52, starting at Week 0. The subcutaneous dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered

Study groups in NCT03961815
Study group	Role	What they receive
Brazikumab Induction Dose	Experimental	Administer at Week 0, Week 4, and Week 8 Receives: Drug: Brazikumab Induction Dose
Brazikumab Maintenance Dose	Experimental	Administer at 4-week intervals through Week 52 Participants who receive IV induction dosing will be administered brazikumab SC at 4-week intervals starting Week 12 through Week 52 Receives: Drug: Brazikumab Maintenance Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Number and percentage of patients with reported adverse events
Measured: Through Week 70
Laboratory Values
Number and percentage of patients with Potentially Clinically Significant Postbaseline results in hematology, clinical chemistry, urinalysis.
Measured: through Week 70
Vital Signs
Number and percentage of patients with Potentially Clinically Significant results in systolic and diastolic blood pressure, pulse rate and weight.
Measured: through Week 70
ECG
Number and percentage of patients with Potentially Clinically Significant results in 12-lead ECG recordings.
Measured: through Week 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202019 Sep 2023

First posted23 May 2019
Study start6 Jan 2020
Primary completion19 Sep 2023
Study completion19 Sep 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 Crohn's DiseaseStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03961815
Sponsor's protocol ID: D5271C00002
Other IDs: #3150-303-008, 2019-001866-14, 2019
Acronym: INTREPID OLE
Status last verified: Mar 2026
First submitted: 8 May 2019
Last updated: 1 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)
ClinicalTrials.gov ID: NCT03961815
Acronym / sponsor ID: INTREPID OLE / D5271C00002
Conditions: Crohn's Disease, IBD
Keywords: Crohn's Disease, Inflammatory bowel disease, Brazikumab, IL23 receptor, IBD, CD
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Enrolment: 18 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Jan 2020 (actual)
Primary completion: 19 Sep 2023 (actual)
Study completion: 19 Sep 2023 (actual)
First posted: 23 May 2019 (actual)
Results: Posted 1 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Brazikumab Induction Dose	Experimental	Drug: Brazikumab Induction DoseAdminister at Week 0, Week 4, and Week 8
Brazikumab Maintenance Dose	Experimental	Drug: Brazikumab Maintenance DoseAdminister at 4-week intervals through Week 52 Participants who receive IV induction dosing will be administered brazikumab SC at 4-week intervals starting Week 12 through Week 52

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male or female participants with successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008).
Meets 1 of the following criteria for successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008):
Criterion deleted as part of Amendment.
Each participant must have had the ileocolonoscopic procedure at the final visit (Week 52, Week 12, or early termination after Week 12 of Study D5271C00001 (Legacy # 3150-301-008).
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 (confirmed by the investigator) from signing the ICF throughout the study duration and for at least 18 weeks after last dose of study intervention.

Key exclusion criteria (22 listed)

Any participant with an unresolved AE from the Study D5271C00001 (Legacy #3150 301-008) that would limit the participant's ability to participate in or complete this study.
Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primary sclerosing cholangitis.
Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
Any other condition or finding that, in the investigator's or sponsor's opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk.
History of cancer except for basal cell and/or squamous cell carcinoma of the skin, and carcinoma in situ of the cervix within 12 months of screening.

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
Brazikumab Induction DoseParticipants who met criteria for early termination due to lack of efficacy (rescue treatment criteria) or who did not meet CDAI response at Week 52 in the lead-in study D5121C00001 are considered inadequate/non responders, and will receive IV induction dosing brazikumab at Week 0, Week 4, and Week 8 followed by maintenance dosing of brazikumab subcutaneously every 4 weeks thereafter up to Week 52.	Drug	Brazikumab Induction Dose
Brazikumab Maintenance DoseResponders from Lead-In study D5271C00001 who completed requirements through Week 52 and met CDAI response (CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points) without ongoing rescue treatment at Week 52 in the lead-in study. will receive maintenance dose of brazikumab administered subcutaneously every 4 weeks through Week 52, starting at Week 0. The subcutaneous dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered	Drug	Brazikumab Maintenance Dose

Primary outcome

Adverse Events
Time frame: Through Week 70
Number and percentage of patients with reported adverse events
Laboratory Values
Time frame: through Week 70
Number and percentage of patients with Potentially Clinically Significant Postbaseline results in hematology, clinical chemistry, urinalysis.
Vital Signs
Time frame: through Week 70
Number and percentage of patients with Potentially Clinically Significant results in systolic and diastolic blood pressure, pulse rate and weight.
ECG
Time frame: through Week 70
Number and percentage of patients with Potentially Clinically Significant results in 12-lead ECG recordings.

Results and safety

Results posted to the registry on 1 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brazikumab/Brazikumab	12	5
Placebo/Brazikumab	4	1
Adalimumab/Brazikumab	2	2

Primary outcome: Adverse Events

Time frame: Through Week 70. Count of participants. Unit: Participants

Measure	Brazikumab/Brazikumab n = 12	Placebo/Brazikumab n = 4	Adalimumab/Brazikumab n = 2
Any adverse event	11	1	1
No adverse events noted	1	3	1

Population analysed: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.

Primary outcome: Laboratory Values

Time frame: through Week 70. Count of participants. Unit: Participants

Measure	Brazikumab/Brazikumab n = 11	Placebo/Brazikumab n = 4	Adalimumab/Brazikumab n = 2
Eosinophils/Leukocytes (%): High	1	0	0
Eosinophils/Leukocytes (%): Normal	10	4	2
Eosinophils/Leukocytes (%): Low	0	0	0
Hematocrit (RATIO): High	0	0	0
Hematocrit (RATIO): Normal	7	1	1
Hematocrit (RATIO): Low	4	3	1
Hemoglobin (g/L): High	0	0	0
Hemoglobin (g/L): Normal	9	4	1

Population analysed: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study. Participants with a baseline value and at least one post-baseline value are included in the analysis.

Primary outcome: Vital Signs

Time frame: through Week 70. Count of participants. Unit: Participants

Measure	Brazikumab/Brazikumab n = 12	Placebo/Brazikumab n = 4	Adalimumab/Brazikumab n = 2
Sitting systolic blood pressure (mmHg): High	3	1	0
Sitting systolic blood pressure (mmHg): Normal	8	3	2
Sitting systolic blood pressure (mmHg): Low	1	0	0
Sitting diastolic blood pressure (mmHg): High	6	0	1
Sitting diastolic blood pressure (mmHg): Normal	4	3	1
Sitting diastolic blood pressure (mmHg): Low	2	1	0
Sitting pulse rate (bpm): High	3	1	0
Sitting pulse rate (bpm): Normal	7	2	2

Primary outcome: ECG

Time frame: through Week 70. Count of participants. Unit: Participants

Measure	Brazikumab/Brazikumab n = 12	Placebo/Brazikumab n = 4	Adalimumab/Brazikumab n = 2
Abnormal	2	0	0
Normal	7	4	2
No data	3	0	0

Adverse events

Time frame: Through week 70. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brazikumab/Brazikumab	2 of 12 (16.7%)	11 of 12 (91.7%)	0 of 12
Placebo/Brazikumab	1 of 4 (25%)	1 of 4 (25%)	0 of 4
Adalimumab/Brazikumab	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Limitations and caveats (from the sponsor): The study was early terminated and development of brazikumab stopped. Following cessation of development all study related dosing was immediately stopped. Site data cleaning engagement proved challenging. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). However, the database was locked with unclean data for the outcome measures. Please be aware that the data submitted needs to be considered with the data quality in mind.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Redacted CSR synopsisLink provided by the sponsor.
Redacted CSPLink provided by the sponsor.
Redacted SAPLink 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.

Related trials for Crohn's Disease

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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

15 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brazikumab Induction Dose and Brazikumab Maintenance Dose in people with Crohn's Disease and IBD, run by AstraZeneca at 15 sites in 5 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 16 inclusion and 22 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, South Africa, Germany, Poland, Taiwan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Apr 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?

Adverse Events (time frame: Through Week 70). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03961815.

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 1 Apr 2026.