Ulcerative ColitisPhase 2COMBO-UCNCT06453317
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
A Phase 2 study testing Infliximab and Ustekinumab in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Infliximab and Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 sitePoland
- Study dates
- 17 Feb 2025to 30 Jun 2028
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.
- Age ≥ 18 years and ≤65 at the time of screening.
- In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6 months after receiving the last dose of the drug.
- For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient participates in the study and for a period counted from the last dose of 15 weeks if using UST (patients in arms B and C) or 6 months if using IFX (patients in arm A).
- Negative serum or urine pregnancy test in women of childbearing age.
- Diagnosis of UC a minimum of. 3 months prior to screening documented by:
Show all 21Show fewer
- medical source documentation of the patient with the result of an endoscopic examination that diagnosed features typical of UC.
- a histopathological examination result consistent with UC. In the absence of a histopathological result, it is possible to take sections during the endoscopic examination for histopathological evaluation at the time of eligibility for the study with subsequent sending of the material to the local pathomorphology laboratory to confirm the diagnosis of UC before randomization.
- UC with moderate or severe activity defined as a Mayo scale score (Appendix 2) of 7 to 12 including the following sub-item values (each sub-item 0-3 points depending on the severity of the lesions):
- Frequency of bowel movements
- Bowel bleeding
- Endoscopic image of the colonic mucosa
- General medical evaluation and:
- with inadequate response to standard treatment, including corticosteroids and 6-mercaptopurine or azathioprine, or.
- intolerant of treatment with corticosteroids and 6-mercaptopurine or azathioprine, or
- having contraindications to treatment with corticosteroids and 6-mercaptopurine or azathioprine, or
- with loss of response to standard treatment, including to treatment with corticosteroids and 6-mercaptopurine or azathioprine, including patients:
- Steroid-resistant - in whom there is no clinical improvement despite the use of a daily steroid up to 0.75 mg/kg prednisolone for 4 weeks;
- Steroid-dependent - in whom failure to reduce the steroid dose below 10 mg/day, converted to prednisolone, within 3 months of starting steroid therapy or relapse of complaints within 3 months of steroid withdrawal.
- Refractory patients/about inadequate response to immunosuppressive treatment, defined as lack of remission or recurrence of complaints despite immunosuppressive treatment for at least 3 months at appropriate doses (azathioprine 2-2.5 mg/kg/day or 6-mercaptopurine 1-1.5 mg/kg/day).
- Patients taking 5-ASA derivatives, corticosteroids, immunosuppressants may be included in the study if they are taking a fixed and specified dose of the above drugs 14 days before the day of randomization.
Who cannot join
- Previous use of the study drug IFX or UST.
- Hypersensitivity to the active substance or excipients.
- Moderate or severe myocardial insufficiency (NYHA III or IV).
- Unstable coronary artery disease.
- History of serious cerebrovascular disease (stroke, intracranial hemorrhage, transient cerebral ischemia) within the last 24 weeks prior to screening.
- Chronic respiratory failure.
Show all 34Show fewer
- Severe chronic renal failure.
- Severe chronic liver failure.
- Demyelinating syndrome or symptoms resembling the syndrome.
- Alcoholic disease, post-alcoholic liver damage.
- Diagnosis of malignant neoplasms, including within 5 years preceding the time of eligibility for the program (except for carcinoma in situ of the cervix, and non-melanoma skin cancers).
- 12 Complications requiring other management (e.g., surgery). 13. Current or recent (defined as an incident within 12 weeks prior to randomization) documented episode of fulminant colitis, or intra-abdominal abscess, or acute colonic distension, or bowel perforation.
- 14. Status after extensive colorectal resection, subtotal or total colectomy with or without colostomy, or J-pouch reservoir.
- 15. Indication of surgical intervention due to underlying disease or when there is a suspicion of need for such intervention during the course of the study.
- 16. History of current or previously documented unclassified colitis or ischemic colitis.
- 17. History of colonic diverticulitis within the last 60 days prior to the randomization visit.
- 18. Current adenomatous polyps of the colon, small- or large-grade dysplasia in colon specimens, or previously diagnosed foci of large-grade dysplasia that have not been treated.
- 19. Enteral nutrition or total parenteral nutrition. 20. Pregnancy or breastfeeding. 21. Taking medications on the prohibited drugs list (Section 7.4.6). 22. daily dose of prednisone> 40 mg (or equivalent other corticosteroid) or budesonide MMX > 9 mg.
- 23. Status after bone marrow transplantation. 24. Condition after apheresis 12 months prior to the randomization visit. 25. Period after administration of allowed biologic drugs shorter than the drug's washout period from the body (Section 7.2).
- 26. Period after intestinal microbiota transplantation less than 8 weeks before signing informed consent to participate in the study.
- 27. Active or latent form of tuberculosis. 28. HIV infection. 29. Treatment period for active lesions of chronic infections (including pneumocystodosis, CMV, HPV, HSV infection, atypical mycobacteriosis, invasive bacterial or fungal infections).
- 30 History of HSV, HPV, influenza virus, SARS-CoV2 infection within 12 weeks prior to randomization or history of disseminated or complicated HSV infection.
- 31. History of congenital or acquired immunodeficiency. 32. receipt of live vaccine within 30 days prior to randomization. 33. infection with HBV or HCV. 34. Clinically significant changes on chest X-ray or ECG. 35 Clinically significant changes observed in laboratory test results:
- ALT activity >3x the upper limit of normal (GGN)
- AST activity >3x GGN
- Total bilirubin level >2x GGN (exception is Gilbert syndrome when other causes of isolated hyperbilirubinemia are excluded).
- ALP or GGTP activity >3x GGN
- Creatinine level >2x GGN or impaired renal function (eGFR) <45mL/min calculated by MDRD formula.
- Hemoglobin level <9g/dL
- Absolute leukocyte count <3000/mm3
- Absolute lymphocyte count <750/mm3
- Neutrophil level <1000/mm3
- Platelet level <100000/mm3. 36. Positive stool culture for bacteria/fungus (if clinically relevant in the opinion of the investigator).
- 37.Positive stool culture for Clostridioides difficile. 38. Use of treatment not permitted under this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej USK nr 1 im. N. Barlickiego w Łodzi
Lodz, 90-153
Adam Fabisiak, PhD, +48426776667, adam.fabisiak@umed.lodz.pl
About this study
Official title: Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis (COMBO-UC)
The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are:
Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy?
Read more
Participants:
Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab).
Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- Infliximab, Ustekinumab
- Keywords
- dual biological therapy, infliximab, ustekinumab, Inflammatory Bowel Diseases, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Infliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks.
UstekinumabBiological
Ustekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight >55-≤85 kg 390 mg, patients with body weight >85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Active comparator | Infliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks. Receives: Biological: Infliximab |
| Ustekinumab | Active comparator | Ustekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight >55-≤85 kg 390 mg, patients with body weight >85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks. Receives: Biological: Ustekinumab |
| Infliximab + Ustekinumab | Experimental | Infliximab 5 mg/kg i.v. at Week 0, 2, 6.
+ Ustekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight >55-≤85 kg 390 mg, patients with body weight >85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks Receives: Biological: Infliximab; Biological: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical and endoscopic remission after the induction phase.
Clinical remission: PRO-2 score ≤1 points, total Mayo score <3 Endoscopic remission: endoscopic Mayo score ≤1
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms
Secondary outcomes (8)
Percentage of patients with clinical response after the induction phase.
Clinical response: change in PRO-2 score ≥50% or a change in total Mayo score ≥3 points
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms
Percentage of patients with clinical response at Week 52.
Clinical response: change in PRO-2 score ≥50% or a change in total Mayo score ≥3 points
Measured: Week 52
Percentage of patients with clinical remission at Week 52.
Clinical remission: PRO-2 score ≤1 points, total Mayo score <3
Measured: Week 52
Percentage of patients with endoscopic response or remission after the induction phase and at Week 52
Endoscopic response: change in endoscopic Mayo score ≥1 point Endoscopic remission: endoscopic Mayo score ≤1
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Percentage of patients with biochemical remission after the induction phase and at Week 52.
Biochemical remission: calprotectin level ≤125 µg/g of stool
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Percentage of patients with histological remission after the induction phase.
Deep remission: PRO-2 score = 0 points, endoscopic Mayo score = 0 points and Picasso Histologic Remission Index = 0 points
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms
Comparison of patients' quality of life after the induction phase and at Week 52 using 36-Item Short Form Survey (SF-36) and Inflammatory Bowel Disease Questionnaire (IBDQ).
SF-36: 0-100 points (a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability).
IBDQ: 32-224 points (higher scores representing better quality of life).
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Comparison of incidence of treatment-emergent adverse events after the induction phase and at Week 52.
Treatment-emergent adverse events and serious adverse events will be assessed
Measured: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start17 Feb 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań, Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz, Medical Research Agency, Poland
- Responsible party
- Principal investigator, Renata Talar-Wojnarowska, Medical University of Lodz
- Investigators
- Renata Talar-Wojnarowska, Prof., Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453317
- Sponsor's protocol ID
- Combo/2022/3
- Other IDs
- 2023-506452-25, 2023
- Acronym
- COMBO-UC
- Status last verified
- Nov 2024
- First submitted
- 24 May 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis (COMBO-UC)
- ClinicalTrials.gov ID
- NCT06453317
- Acronym / sponsor ID
- COMBO-UC / Combo/2022/3
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Keywords
- dual biological therapy, infliximab, ustekinumab, Inflammatory Bowel Diseases, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań, Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz, Medical Research Agency, Poland
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Jun 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 goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are:
Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy?
Participants:
Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab).
Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Active comparator | Biological: InfliximabInfliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks. |
| Ustekinumab | Active comparator | Biological: UstekinumabUstekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight >55-≤85 kg 390 mg, patients with body weight >85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks. |
| Infliximab + Ustekinumab | Experimental | Biological: Infliximab, Biological: UstekinumabInfliximab 5 mg/kg i.v. at Week 0, 2, 6. + Ustekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight >55-≤85 kg 390 mg, patients with body weight >85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.
- Age ≥ 18 years and ≤65 at the time of screening.
- In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6 months after receiving the last dose of the drug.
- For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient participates in the study and for a period counted from the last dose of 15 weeks if using UST (patients in arms B and C) or 6 months if using IFX (patients in arm A).
- Negative serum or urine pregnancy test in women of childbearing age.
Key exclusion criteria (34 listed)
- Previous use of the study drug IFX or UST.
- Hypersensitivity to the active substance or excipients.
- Moderate or severe myocardial insufficiency (NYHA III or IV).
- Unstable coronary artery disease.
- History of serious cerebrovascular disease (stroke, intracranial hemorrhage, transient cerebral ischemia) within the last 24 weeks prior to 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 |
|---|---|---|
| InfliximabInfliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks. | Biological | Infliximab, Infliximab + Ustekinumab |
| UstekinumabUstekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight >55-≤85 kg 390 mg, patients with body weight >85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks. | Biological | Infliximab + Ustekinumab, Ustekinumab |
Primary outcome
Percentage of patients with clinical and endoscopic remission after the induction phase.
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms
Clinical remission: PRO-2 score ≤1 points, total Mayo score <3 Endoscopic remission: endoscopic Mayo score ≤1
8 secondary outcomes
Percentage of patients with clinical response after the induction phase.
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms
Percentage of patients with clinical response at Week 52.
Time frame: Week 52
Percentage of patients with clinical remission at Week 52.
Time frame: Week 52
Percentage of patients with endoscopic response or remission after the induction phase and at Week 52
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Percentage of patients with biochemical remission after the induction phase and at Week 52.
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Percentage of patients with histological remission after the induction phase.
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms
Comparison of patients' quality of life after the induction phase and at Week 52 using 36-Item Short Form Survey (SF-36) and Inflammatory Bowel Disease Questionnaire (IBDQ).
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
Comparison of incidence of treatment-emergent adverse events after the induction phase and at Week 52.
Time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms and Week 52
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 15 May 2025.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
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.
Renata Talar-Wojnarowska, Prof. principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab and Ustekinumab in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Medical University of Lodz at 1 site in Poland.
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 21 inclusion and 34 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Renata Talar-Wojnarowska, Prof. (+48426776664, renata.talar-wojnarowska@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinical and endoscopic remission after the induction phase. (time frame: Week 14 for Infliximab arm and Week 16 for Ustekinumab and Infliximab + Ustekinumab arms). 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 15 May 2025.