Ulcerative ColitisPhase 2NCT06636656

A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis

A Phase 2 study testing BI 3032950 intravenous (Part A) and BI 3032950 subcutaneous (Part B) in people with Ulcerative Colitis, run by Boehringer Ingelheim at 41 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis. 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?: BI 3032950 intravenous (Part A) and BI 3032950 subcutaneous (Part B)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 41 sitesin 6 countries
Study dates: 11 Dec 2024to 30 Jul 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

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

Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
Further inclusion criteria apply.

Who cannot join

Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
Evidence of fulminant colitis or toxic megacolon at screening,
Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,

Show all 9Show fewer

Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
Further exclusion criteria apply.

Trial locations and contacts

41 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Country

City, postcode or hospital

Sites recruiting now only

41 sites in 6 countries

Poland15 sites, 15 recruiting

Centrum Medyczne Plejady
Krakow, 30-363
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Medrise Sp. z o.o.
Lublin, 20-582
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Eskulap Pabianice Sp. z o.o.
Pabianice, 95-200
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
EMC Instytut Medyczny S.A. - Poznan 70-304
Poznan, 60-309
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Poznan, 61-731
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Centrum Medyczne Medyk Sp. z o.o.
Rzeszów, 35-326
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Endoskopia Sp. z o.o.
Sopot, 81-756
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Szczecin, 71-434
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Gastromed Sp. z o.o.
Torun, 87-100
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Synexus Polska Sp. z o.o.
Warsaw, 02-672
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
NZOZ VIVAMED Jadwiga Miecz
Warsaw, 03-580
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
Włocławek, 87-800
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
PlanetMed Sp. z o.o.
Wroclaw, 52-210
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
EMC Instytut Medyczny S.A. - Wroclaw
Wroclaw, 54-239
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Pro Life Medica Sp. z o.o.
Zamość, 22-400
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting

Other trials in Poland

United States14 sites, 14 recruiting

Texas Digestive Disease Consultants
Cedar Park, Texas, 78613
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Atrium Health Gastroenterology and Hepatology
Charlotte, North Carolina, 28204-2963
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Illinois Gastroenterology Group - Gurnee
Gurnee, Illinois, 60031
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103-2937
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Primary Care of Osceola
Kissimmee, Florida, 34741
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Florida Research Institute
Lakewood Rch, Florida, 34211
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
University of Miami
Miami, Florida, 33136
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Reliant Medical Research
Miami, Florida, 33165-3639
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Columbia University Medical Center
New York, New York, 10032-3725
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
One of a Kind Clinical Research Center
Scottsdale, Arizona, 85258
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Washington
Seattle, Washington, 98195-0001
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Digestive Health Specialists
Tacoma, Washington, 98405-2318
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting

Other trials in United States

Serbia4 sites, 4 recruiting

Clinical Hospital Center Zvezdara
Belgrade, 11000
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Recruiting
Military Medical Academy
Belgrade, 11040
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Not yet recruiting
Clinical Center Zemun
Belgrade, 11080
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Not yet recruiting
General Hospital - Djordje Joanovic
Zrenjanin, 23101
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Recruiting

Other trials in Serbia

Slovakia4 sites, 4 recruiting

F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 975 17
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
Recruiting
ENDOMED s.r.o.
Košice, 040 13
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
Recruiting
KM Management, spol. s.r.o.
Nitra, 949 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
Recruiting
Gastro I., s.r.o
Prešov, 080 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
Recruiting

Other trials in Slovakia

Belgium2 sites, 2 recruiting

UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Recruiting
CHC MontLegia
Liège, 4000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Recruiting

Other trials in Belgium

Czechia2 sites, 2 recruiting

Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
Not yet recruiting
ISCARE a.s.
Prague, 190 00
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
Recruiting

Other trials in Czechia

About this study

Official title: Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis

This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.

Participants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body.

The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions: Ulcerative Colitis
Being tested: BI 3032950 intravenous (Part A), BI 3032950 subcutaneous (Part B)
Medical subject headings: Colitis, Ulcerative

What participants receive

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

BI 3032950 intravenous (Part A)Drug
BI 3032950 intravenous (Part A)
BI 3032950 subcutaneous (Part B)Drug
BI 3032950 subcutaneous (Part B)

Study groups in NCT06636656
Study group	Role	What they receive
All participants	Experimental	All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B. Receives: Drug: BI 3032950 intravenous (Part A); Drug: BI 3032950 subcutaneous (Part B)

What is being measured

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

Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1
The modified Mayo score (mMS) consists of 3 components
1. Stool frequency subscore (SFS)
2. Rectal bleeding subscore (RBS)
3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.
Measured: Up to Week 12

Secondary outcomes (7)

Endoscopic remission (defined as centrally-read ESS of 0)
The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Measured: Up to Week 12
Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)
The modified Mayo score (mMS) consists of 3 components
1. Stool frequency subscore (SFS)
2. Rectal bleeding subscore (RBS)
3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.
Measured: Up to Week 12
Endoscopic improvement (defined as centrally-read ESS of 0 or 1)
The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Measured: Up to Week 12
Modified Mayo Score change from baseline
The modified Mayo score (mMS) consists of 3 components
1. Stool frequency subscore (SFS)
2. Rectal bleeding subscore (RBS)
3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.
Measured: Up to Week 12
Stool frequency subscore of 0 or 1
The stool frequency (SFS) is graded from 0 = none to 3 = severe. The SFS is part of the modified Mayo score.
Measured: Up to Week 12
Rectal bleeding subscore of 0
The rectal bleeding subscore (RBS) is graded from 0 = none to 3 = severe. The RBS is part of the modified Mayo score.
Measured: Up to Week 12
Occurrence of treatment-emergent adverse events (AEs)
Measured: Up to Week 12 and up to Week 104

Timeline

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

11 Dec 202430 Jul 2029

First posted15 Oct 2024
Study start11 Dec 2024
Primary completion30 Jul 2027 (estimated)
Study completion30 Jul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Not applicable
Intervention model: Sequential
Model description: The study consists of Part A and Part B.
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06636656
Sponsor's protocol ID: 1486-0006
Other IDs: 2023-509544-10-00, U1111-1300-3640, 2023
Status last verified: Aug 2026
First submitted: 7 Oct 2024
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.

Interested in taking part?

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

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 sites and contacts

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT06636656
Acronym / sponsor ID: 1486-0006
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 11 Dec 2024 (actual)
Primary completion: 30 Jul 2027 (estimated)
Study completion: 30 Jul 2029 (estimated)
First posted: 15 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

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

The doctors also regularly check participants' health and take note of any unwanted effects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: The study consists of Part A and Part B.

Arm	Type	Receives
All participants	Experimental	Drug: BI 3032950 intravenous (Part A), Drug: BI 3032950 subcutaneous (Part B)All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.

Who may qualify

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

Key inclusion criteria (5 listed)

Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
Further inclusion criteria apply.

Key exclusion criteria (9 listed)

Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
Evidence of fulminant colitis or toxic megacolon at 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
BI 3032950 intravenous (Part A)BI 3032950 intravenous (Part A)	Drug	All participants
BI 3032950 subcutaneous (Part B)BI 3032950 subcutaneous (Part B)	Drug	All participants

Primary outcome

Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1
Time frame: Up to Week 12
The modified Mayo score (mMS) consists of 3 components 1. Stool frequency subscore (SFS) 2. Rectal bleeding subscore (RBS) 3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.

7 secondary outcomes

Endoscopic remission (defined as centrally-read ESS of 0)
Time frame: Up to Week 12
Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)
Time frame: Up to Week 12
Endoscopic improvement (defined as centrally-read ESS of 0 or 1)
Time frame: Up to Week 12
Modified Mayo Score change from baseline
Time frame: Up to Week 12
Stool frequency subscore of 0 or 1
Time frame: Up to Week 12
Rectal bleeding subscore of 0
Time frame: Up to Week 12
Occurrence of treatment-emergent adverse events (AEs)
Time frame: Up to Week 12 and up to Week 104

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.

Related trials for Ulcerative Colitis

Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
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Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
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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.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

41 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 3032950 intravenous (Part A) and BI 3032950 subcutaneous (Part B) in people with Ulcerative Colitis, run by Boehringer Ingelheim at 41 sites in 6 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Poland, United States, Serbia, Slovakia, Belgium and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1 (time frame: Up to Week 12). 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 NCT06636656.

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 21 Aug 2026.