Ulcerative ColitisPhase 2ExpeditionNCT04277546

Open-label Extension Study of Brazikumab in Ulcerative Colitis

A Phase 2 study testing Brazikumab Maintenance Dose and Brazikumab Induction Dose in people with Ulcerative Colitis, run by AstraZeneca at 36 sites in 11 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 this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Brazikumab Maintenance Dose and Brazikumab Induction Dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 36 sitesin 11 countries
Study dates: 3 Mar 2020to 10 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

1.01 Male or female participants who: successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001 (Legacy #3151-201-008). AND Meets 1 of the following criteria for successful completion or early termination from Study D5272C00001 (Legacy #3151-201-008):
Participant completed Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, completed scheduled visits, and completed Week 54 assessments.
Participant discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, and completed Early Termination Visit assessments.
1.02. Deleted Eligibility as part of Amendment 2 1.03. Deleted Eligibility as part of Amendment 3 1.04. Deleted eligibility as part of Amendment 2 2.01. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Nonsterilized men who are sexually active with a female partner of childbearing potential should use condom during treatment and for 18 weeks after the last dose of study intervention, must comply with the methods of contraception described in Criterion 2.02 below, and must not donate or bank sperm for fertilization purpose for the same time period.
2.02. 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 2.03. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
3.01. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

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Written informed consent from the participant has been obtained prior to any study related procedures.
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
4.01. Demonstration of adequate compliance with the study procedures in Study D5272C00001 (Legacy #3151-201-008), in the opinion of the investigator and/or sponsor.
4.02. Willingness and ability to attend all study visits, comply with the study procedures, and be able to complete the study period.
5.01 Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF.
Complete inclusion criteria are in the study protocol

Who cannot join

1.01. Any participant with an unresolved AE from the lead-in study that, in the investigator's opinion, would limit the participant's ability to participate in or complete this study. Any unresolved AE related to an infection will require further discussion with the study physician/designee prior to enrollment.
1.02. Current diagnosis of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline.
1.03. Organ or cell-based transplantation with the exception of corneal transplant.
1.04. 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.
1.05. The following are exclusionary with regards to malignancy:
Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy, the participant must be excluded.

Show all 23Show fewer

Any diagnosis of malignancy that requires discontinuation of study intervention from lead-in study.
Any new diagnosis of malignancy after completion of the lead-in study. d) Carcinoma in situ of the cervix, with apparent successful curative therapy within 12 months prior to Week 0.
1.06. Participant meets criteria for discontinuation of study intervention during prior lead-in study.
1.07. Deleted exclusion criterion as part of Amendment 3 1.08. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, including HIV infection.
1.09. Prolonged QTcF interval or conditions leading to additional risk for QT prolongation. Participants with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolongation are to be corrected prior to enrollment.
1.010. 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 Modification of Diet in Renal Disease equation, asapplicable, by the central laboratory at screening are excluded.
2.01. Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication in the protocol), biological treatment or prohibited treatment 2.02. Deleted eligibility as part of Amendment 2 2.03. Participant received a prohibited medication during participation in the D5272C00001 (Legacy #3151-201-008) study.
2.04. Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 or any other live vaccine < 4 weeks prior to Week 0, or is planning to receive any such vaccine over the course of the study.
2.05. Participant has received an investigational product after discontinuation from Study D5272C00001 (Legacy #3151-201-008) and prior to enrolling in this study or participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5272C00002 (Legacy #3151-202-008).
3.01. Participant who discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 and did not receive all 3 IV infusions of study interventions scheduled for Week 0 (Day 1), Week 2 (Day 15), and Week 6 (Day 43), and SC at Week 10 (Day 71) in accordance with the protocol for Study D5272C00001.
3.02. Participant who discontinued due to lack of efficacy after Week 10 in Study D5272C00001 (Legacy #3151-201-008) but currently demonstrates clinical response and/or meets endoscopic Mayo Score of 0 or 1 prior to Week 54 in Study D5272C00001 (Legacy #3151-201-008): Clinical Response 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, in Study D5272C00001 (Legacy #3151-201-008). Note: Participants are encouraged to remain in the lead-in Study D5272C00001 (Legacy #3151-201-008) if the participant is demonstrating evidence of clinical response. Participants should not early terminate that study due to lack of efficacy if this exclusion is met.
4.01. Abnormal laboratory results at screening as described in the protocol. 5.01. Females who are pregnant, breast feeding, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use contraception consistently and correctly as required by the study protocol.
5.02. Participant is directly or indirectly involved in the planning and/or conduct and administration of this study as study staff member, or employee of the sponsor, 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.
5.03. Judgment that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
5.04. Previous enrollment in the present study.
Complete exclusion criteria are in the study protocol

Trial locations and contacts

36 sites in 11 countries.

Country

City, postcode or hospital

36 sites in 11 countries

United States10 sites

Research Site
Beachwood, Ohio, 44122
Research Site
Chula Vista, California, 91911
Research Site
Colorado Springs, Colorado, 80907
Research Site
Evansville, Indiana, 47715
Research Site
Humble, Texas, 77346
Research Site
Lakeland, Florida, 33813
Research Site
Lancaster, California, 93534
Research Site
Miami, Florida, 33165
Research Site
Miami Lakes, Florida, 33016
Research Site
Oklahoma City, Oklahoma, 73112

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Poland6 sites

Research Site
Krakow, 31-513
Research Site
Rzeszów, 35-302
Research Site
Sopot, 81-756
Research Site
Torun, 87-100
Research Site
Warsaw, 00-189
Research Site
Warsaw, 03-580

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Germany3 sites

Research Site
Hamburg, 20251
Research Site
Kiel, 24105
Research Site
Ulm, 89081

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Italy3 sites

Research Site
Milan, 20132
Research Site
Rho, 20017
Research Site
Roma, 00168

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Japan3 sites

Research Site
Kasama-shi, 309-1793
Research Site
Kashiwa-shi, 277-0871
Research Site
Minatoku, 108-8642

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South Africa3 sites

Research Site
Cape Town, 7500
Research Site
Cape Town, 7708
Research Site
Plumstead, 7800

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Czechia2 sites

Research Site
České Budějovice, 370 01
Research Site
Ostrava, 702 00

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Israel2 sites

Research Site
Haifa, 3109601
Research Site
Jerusalem, 9103102

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Taiwan2 sites

Research Site
Taichung, 40447
Research Site
Taipei, 10002

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Puerto Rico1 site

Research Site
San Juan, 00927

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South Korea1 site

Research Site
Wŏnju, 26426

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About this study

Official title: A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)

Conditions: Ulcerative Colitis
Being tested: Brazikumab Maintenance Dose, Brazikumab Induction Dose
Medical subject headings: Colitis, Ulcerative

What participants receive

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

Brazikumab Maintenance DoseDrug
Completers in the lead-in study D5272C00001 (Legacy #3151-201-008) will receive a maintenance dose of brazikumab administered subcutaneously every 4 weeks up to Week 52 (Group A). The SC dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered.
Brazikumab Induction DoseDrug
Participants in the lead-in study D5272C00001 (Legacy #3151-201-008) who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab administered subcutaneously every 4 weeks thereafter (up to Week 52).

Study groups in NCT04277546
Study group	Role	What they receive
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
Brazikumab Induction Dose	Experimental	Administer at Week 0, Week 4, and Week 8 Receives: Drug: Brazikumab Induction 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
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Measured: Through Week 70
Vital Signs
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Measured: Through Week 70
ECG
Percentage of patients with potentially clinically significant changes 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.

3 Mar 202010 Oct 2023

First posted20 Feb 2020
Study start3 Mar 2020
Primary completion10 Oct 2023
Study completion10 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04277546
Sponsor's protocol ID: D5272C00002
Other IDs: #3151-202-008, 2021-001644-10
Acronym: Expedition
Status last verified: May 2026
First submitted: 18 Feb 2020
Last updated: 23 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
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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All Ulcerative Colitis trials

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 Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)
ClinicalTrials.gov ID: NCT04277546
Acronym / sponsor ID: Expedition / D5272C00002
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Enrolment: 57 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 3 Mar 2020 (actual)
Primary completion: 10 Oct 2023 (actual)
Study completion: 10 Oct 2023 (actual)
First posted: 20 Feb 2020 (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.

Study design

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

Arm	Type	Receives
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
Brazikumab Induction Dose	Experimental	Drug: Brazikumab Induction DoseAdminister at Week 0, Week 4, and Week 8

Who may qualify

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

Key inclusion criteria (12 listed)

1.01 Male or female participants who: successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001 (Legacy #3151-201-008). AND Meets 1 of the following criteria for successful completion or early termination from Study D5272C00001 (Legacy #3151-201-008):
Participant completed Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, completed scheduled visits, and completed Week 54 assessments.
Participant discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, and completed Early Termination Visit assessments.
1.02. Deleted Eligibility as part of Amendment 2 1.03. Deleted Eligibility as part of Amendment 3 1.04. Deleted eligibility as part of Amendment 2 2.01. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Nonsterilized men who are sexually active with a female partner of childbearing potential should use condom during treatment and for 18 weeks after the last dose of study intervention, must comply with the methods of contraception described in Criterion 2.02 below, and must not donate or bank sperm for fertilization purpose for the same time period.
2.02. 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 2.03. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.

Key exclusion criteria (23 listed)

1.01. Any participant with an unresolved AE from the lead-in study that, in the investigator's opinion, would limit the participant's ability to participate in or complete this study. Any unresolved AE related to an infection will require further discussion with the study physician/designee prior to enrollment.
1.02. Current diagnosis of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline.
1.03. Organ or cell-based transplantation with the exception of corneal transplant.
1.04. 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.
Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy, the participant must be excluded.

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 Maintenance DoseCompleters in the lead-in study D5272C00001 (Legacy #3151-201-008) will receive a maintenance dose of brazikumab administered subcutaneously every 4 weeks up to Week 52 (Group A). The SC 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
Brazikumab Induction DoseParticipants in the lead-in study D5272C00001 (Legacy #3151-201-008) who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab administered subcutaneously every 4 weeks thereafter (up to Week 52).	Drug	Brazikumab Induction 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
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Vital Signs
Time frame: Through Week 70
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
ECG
Time frame: Through Week 70
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings.

Results and safety

Results posted to the registry on 23 Jun 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	31	10
Placebo/Brazikumab	24	3
Vedolizumab/Brazikumab	2	2

Primary outcome: Adverse Events

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

Measure	Brazikumab/Brazikumab n = 31	Placebo/Brazikumab n = 24	Vedolizumab/Brazikumab n = 2
Value	15	11	2

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 = 29	Placebo/Brazikumab n = 22	Vedolizumab/Brazikumab n = 2
Hematocrit (RATIO): Low	1	0	0
Hematocrit (RATIO): Normal	28	22	2
Hematocrit (RATIO): High	0	0	0
Hemoglobin (g/L): Low	3	6	0
Hemoglobin (g/L): Normal	26	16	2
Hemoglobin (g/L): High	0	0	0
Alanine Aminotransferase (ukat/L): Low	0	0	0
Alanine Aminotransferase (ukat/L): Normal	29	21	2

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 = 31	Placebo/Brazikumab n = 24	Vedolizumab/Brazikumab n = 2
Sitting systolic blood pressure (mmHg): High	3	3	0
Sitting systolic blood pressure (mmHg): Low	0	0	0
Sitting systolic blood pressure (mmHg): Normal	28	21	2
Sitting diastolic blood pressure (mmHg): High	2	3	0
Sitting diastolic blood pressure (mmHg): Low	0	1	0
Sitting diastolic blood pressure (mmHg): Normal	29	20	2
Sitting pulse rate (bpm): High	1	1	0
Sitting pulse rate (bpm): Low	6	4	0

Primary outcome: ECG

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

Measure	Brazikumab/Brazikumab n = 25	Placebo/Brazikumab n = 24	Vedolizumab/Brazikumab n = 2
Value	3	3	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	1 of 31 (3.2%)	15 of 31 (48.4%)	0 of 31
Placebo/Brazikumab	0 of 24 (0%)	11 of 24 (45.8%)	0 of 24
Vedolizumab/Brazikumab	0 of 2 (0%)	2 of 2 (100%)	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 23 Jun 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 Ulcerative Colitis

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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

36 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brazikumab Maintenance Dose and Brazikumab Induction Dose in people with Ulcerative Colitis, run by AstraZeneca at 36 sites in 11 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 12 inclusion and 23 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 36 sites in United States, Poland, Germany, Italy, Japan and 6 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. 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?

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 NCT04277546.

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.