Ulcerative ColitisNCT06335160
Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
A study testing Mebendazole in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
Trial summary
To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mebendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2024to May 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old Both male and female will be included Mild and moderate UC patients diagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine)
Who cannot join
- - Patients with severe UC
- Significant liver and kidney function abnormalities
- Diabetic patients
- Patients with Colorectal cancer patients
- Patients taking rectal or systemic steroids
- Patients on immunosuppressants or biological therapies
Show all 22Show fewer
- Addiction to alcohol and / or drugs
- Known allergy to the studied medications
- History of complete or partial colectomy.
- Patients with congestive heart failure, other heart disease (arrhythmia, ischemic heart disease including angina and myocardial infarction).
- Patients with other inflammatory diseases and active infection.
- Patients with stressful condition (COPD, morbid obesity).
- Patients with liver disease.
- Patients with thrombocytopenia and neutropenia.
- Patients with any type of seizures (case report for mebendazole induced convulsion).
- Patients with renal disease (case report for mebendazole induced nephrotoxicity).
- Patients with coagulation disorders.
- Patients on metronidazole (to avoid Stevens-Johnson syndrome).
- Patients with hypersensitivity to mebendazole, albendazole or benzimidazole
- Patients using antioxidants.
- Pregnant and lactating females.
- Patients receiving, metronidazole, warfarin, low dose of aspirin, clopidogril, enzyme inducers (phenytoin, carbamazepine) and inhibitors (valoproate) to avoid potential pharmacodynamics and pharmacokinetic interactions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta Unuversity
Tanta, 34518
Eman Elberri, PhD, 01067831661, eman.elberri@pharm.tanta.edu.eg
About this study
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine
Read the detailed description
A randomized, controlled, and parallel study will comprise 46 patients with UC. Patients will be recruited from GastroEnterology Department, Mansoura University Hospital.
The participants will be randomly assigned into two groups as follow:
Group 1: control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.
Group 2: (mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months.
- Conditions
- Ulcerative Colitis
- Being tested
- Mebendazole
- Keywords
- MBZ, UC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MebendazoleDrug
mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months. |
| Treatment Group | Active comparator | Treatment group( mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months Receives: Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in disease activity
Disease severity which will be assessed according to the modified Truelove and Witt's classification based on number of bloody stools per day plus one or more of 4 additional criteria including pulse, temperature, hemoglobin and Erythrocyte sedimentation rate (ESR) . Remission will be defined as disappearance or improvement of symptoms such as normal stool and stooling pattern without blood, no fever, no tachycardia, hemoglobin level normal or returning toward normal, ESR normal or returning toward normal, and patient gaining weight.
Measured: change in baseline
change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity
depends on three items; stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.
Remission is defined as total PMSI = 0-1, mild disease is defined as total PMSI = 2-4, moderate disease is defined as total PMSI = 5-6 and severe disease is defined as total PMSI =7-9.
Measured: change in baseline
Secondary outcomes (6)
Change in Hemoglobin Concentration
Enzyme-linked immunosorbent assay (ELISA)
Measured: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Erythrocyte sedimentation rate (ESR)
Enzyme-linked immunosorbent assay (ELISA)
Measured: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum albumin
Enzyme-linked immunosorbent assay (ELISA)
Measured: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Interleukin -6 (IL-6)
Enzyme-linked immunosorbent assay (ELISA)
Measured: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Nitric oxide (NO)
Enzyme-linked immunosorbent assay (ELISA)
Measured: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Intra cellular adhesion molecule 1 (ICAM-1)
Enzyme-linked immunosorbent assay (ELISA)
Measured: Blood samples will be taken from all patients at baseline then six months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start20 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elberri, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335160
- Sponsor's protocol ID
- Mebendazole Ulcerative Colitis
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersson CR, Selvin T, Blom K, Rubin J, Berglund M, Jarvius M, Lenhammar L, Parrow V, Loskog A, Fryknas M, Nygren P, Larsson R. Mebendazole is unique among tubulin-active drugs in activating the MEK-ERK pathway. Sci Rep. 2020 Aug 4;10(1):13124. doi: 10.1038/s41598-020-68986-0.
PubMed 32753665Elayapillai S, Ramraj S, Benbrook DM, Bieniasz M, Wang L, Pathuri G, Isingizwe ZR, Kennedy AL, Zhao YD, Lightfoot S, Hunsucker LA, Gunderson CC. Potential and mechanism of mebendazole for treatment and maintenance of ovarian cancer. Gynecol Oncol. 2021 Jan;160(1):302-311. doi: 10.1016/j.ygyno.2020.10.010. Epub 2020 Oct 31.
PubMed 33131904Eskandari M, Asgharzadeh F, Askarnia-Faal MM, Naimi H, Avan A, Ahadi M, Vossoughinia H, Gharib M, Soleimani A, Naghibzadeh N, Ferns G, Ryzhikov M, Khazaei M, Hassanian SM. Mebendazole, an anti-helminth drug, suppresses inflammation, oxidative stress and injury in a mouse model of ulcerative colitis. Sci Rep. 2022 Jun 17;12(1):10249. doi: 10.1038/s41598-022-14420-6.
PubMed 35715495Ford AC, Achkar JP, Khan KJ, Kane SV, Talley NJ, Marshall JK, Moayyedi P. Efficacy of 5-aminosalicylates in ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):601-16. doi: 10.1038/ajg.2011.67. Epub 2011 Mar 15.
PubMed 21407188Guerini AE, Triggiani L, Maddalo M, Bonu ML, Frassine F, Baiguini A, Alghisi A, Tomasini D, Borghetti P, Pasinetti N, Bresciani R, Magrini SM, Buglione M. Mebendazole as a Candidate for Drug Repurposing in Oncology: An Extensive Review of Current Literature. Cancers (Basel). 2019 Aug 31;11(9):1284. doi: 10.3390/cancers11091284.
PubMed 31480477Hegazy SK, El-Azab GA, Zakaria F, Mostafa MF, El-Ghoneimy RA. Mebendazole; from an anti-parasitic drug to a promising candidate for drug repurposing in colorectal cancer. Life Sci. 2022 Jun 15;299:120536. doi: 10.1016/j.lfs.2022.120536. Epub 2022 Apr 3.
PubMed 35385794Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8.
PubMed 8759664Jena G, Trivedi PP, Sandala B. Oxidative stress in ulcerative colitis: an old concept but a new concern. Free Radic Res. 2012 Nov;46(11):1339-45. doi: 10.3109/10715762.2012.717692. Epub 2012 Sep 5.
PubMed 22856328Kobayashi T, Siegmund B, Le Berre C, Wei SC, Ferrante M, Shen B, Bernstein CN, Danese S, Peyrin-Biroulet L, Hibi T. Ulcerative colitis. Nat Rev Dis Primers. 2020 Sep 10;6(1):74. doi: 10.1038/s41572-020-0205-x.
PubMed 32913180Puente S, Lago M, Subirats M, Sanz-Esteban I, Arsuaga M, Vicente B, Alonso-Sardon M, Belhassen-Garcia M, Muro A. Imported Mansonella perstans infection in Spain. Infect Dis Poverty. 2020 Jul 23;9(1):105. doi: 10.1186/s40249-020-00729-9.
PubMed 32703283Sturm A, Maaser C, Calabrese E, Annese V, Fiorino G, Kucharzik T, Vavricka SR, Verstockt B, van Rheenen P, Tolan D, Taylor SA, Rimola J, Rieder F, Limdi JK, Laghi A, Krustins E, Kotze PG, Kopylov U, Katsanos K, Halligan S, Gordon H, Gonzalez Lama Y, Ellul P, Eliakim R, Castiglione F, Burisch J, Borralho Nunes P, Bettenworth D, Baumgart DC, Stoker J; European Crohn's and Colitis Organisation [ECCO] and the European Society of Gastrointestinal and Abdominal Radiology [ESGAR]. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 2: IBD scores and general principles and technical aspects. J Crohns Colitis. 2019 Mar 26;13(3):273-284. doi: 10.1093/ecco-jcc/jjy114. No abstract available.
PubMed 30137278Tolomeo M, Colomba C, Meli M, Cascio A. Hepatotoxicity caused by mebendazole in a patient with Gilbert's syndrome. J Clin Pharm Ther. 2019 Dec;44(6):985-987. doi: 10.1111/jcpt.13033. Epub 2019 Aug 18.
PubMed 31423600Wildenberg ME, Levin AD, Ceroni A, Guo Z, Koelink PJ, Hakvoort TBM, Westera L, Bloemendaal FM, Brandse JF, Simmons A, D'Haens GR, Ebner D, van den Brink GR. Benzimidazoles Promote Anti-TNF Mediated Induction of Regulatory Macrophages and Enhance Therapeutic Efficacy in a Murine Model. J Crohns Colitis. 2017 Dec 4;11(12):1480-1490. doi: 10.1093/ecco-jcc/jjx104.
PubMed 28961920Younis NS, Ghanim AMH, Saber S. Mebendazole augments sensitivity to sorafenib by targeting MAPK and BCL-2 signalling in n-nitrosodiethylamine-induced murine hepatocellular carcinoma. Sci Rep. 2019 Dec 13;9(1):19095. doi: 10.1038/s41598-019-55666-x.
PubMed 31836811Zingarelli B, Szabo C, Salzman AL. Reduced oxidative and nitrosative damage in murine experimental colitis in the absence of inducible nitric oxide synthase. Gut. 1999 Aug;45(2):199-209. doi: 10.1136/gut.45.2.199.
PubMed 10403731
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT06335160
- Acronym / sponsor ID
- Mebendazole Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Keywords
- MBZ, UC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 Mar 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.
To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine
Detailed description
A randomized, controlled, and parallel study will comprise 46 patients with UC. Patients will be recruited from GastroEnterology Department, Mansoura University Hospital.
The participants will be randomly assigned into two groups as follow:
Group 1: control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.
Group 2: (mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months. |
| Treatment Group | Active comparator | Drug: MebendazoleTreatment group( mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years old Both male and female will be included Mild and moderate UC patients diagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine)
Key exclusion criteria (22 listed)
- - Patients with severe UC
- Significant liver and kidney function abnormalities
- Diabetic patients
- Patients with Colorectal cancer patients
- Patients taking rectal or systemic steroids
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 |
|---|---|---|
| Mebendazolemebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months | Drug | Treatment Group |
Primary outcome
change in disease activity
Time frame: change in baseline
Disease severity which will be assessed according to the modified Truelove and Witt's classification based on number of bloody stools per day plus one or more of 4 additional criteria including pulse, temperature, hemoglobin and Erythrocyte sedimentation rate (ESR) . Remission will be defined as disappearance or improvement of symptoms such as normal stool and stooling pattern without blood, no fever, no tachycardia, hemoglobin level normal or returning toward normal, ESR normal or returning toward normal, and patient gaining weight.
change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity
Time frame: change in baseline
depends on three items; stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items. Remission is defined as total PMSI = 0-1, mild disease is defined as total PMSI = 2-4, moderate disease is defined as total PMSI = 5-6 and severe disease is defined as total PMSI =7-9.
6 secondary outcomes
Change in Hemoglobin Concentration
Time frame: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Erythrocyte sedimentation rate (ESR)
Time frame: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum albumin
Time frame: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Interleukin -6 (IL-6)
Time frame: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Nitric oxide (NO)
Time frame: Blood samples will be taken from all patients at baseline then six months of therapy
Change in Serum Intra cellular adhesion molecule 1 (ICAM-1)
Time frame: Blood samples will be taken from all patients at baseline then six months of therapy
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 6 Feb 2026.
- Background: PubMed 32753665Andersson CR, Selvin T, Blom K, Rubin J, Berglund M, Jarvius M, Lenhammar L, Parrow V, Loskog A, Fryknas M, Nygren P, Larsson R. Mebendazole is unique among tubulin-active drugs in activating the MEK-ERK pathway. Sci Rep. 2020 Aug 4;10(1):13124. doi: 10.1038/s41598-020-68986-0.
- Background: PubMed 33131904Elayapillai S, Ramraj S, Benbrook DM, Bieniasz M, Wang L, Pathuri G, Isingizwe ZR, Kennedy AL, Zhao YD, Lightfoot S, Hunsucker LA, Gunderson CC. Potential and mechanism of mebendazole for treatment and maintenance of ovarian cancer. Gynecol Oncol. 2021 Jan;160(1):302-311. doi: 10.1016/j.ygyno.2020.10.010. Epub 2020 Oct 31.
- Background: PubMed 35715495Eskandari M, Asgharzadeh F, Askarnia-Faal MM, Naimi H, Avan A, Ahadi M, Vossoughinia H, Gharib M, Soleimani A, Naghibzadeh N, Ferns G, Ryzhikov M, Khazaei M, Hassanian SM. Mebendazole, an anti-helminth drug, suppresses inflammation, oxidative stress and injury in a mouse model of ulcerative colitis. Sci Rep. 2022 Jun 17;12(1):10249. doi: 10.1038/s41598-022-14420-6.
- Background: PubMed 21407188Ford AC, Achkar JP, Khan KJ, Kane SV, Talley NJ, Marshall JK, Moayyedi P. Efficacy of 5-aminosalicylates in ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol. 2011 Apr;106(4):601-16. doi: 10.1038/ajg.2011.67. Epub 2011 Mar 15.
- Background: PubMed 31480477Guerini AE, Triggiani L, Maddalo M, Bonu ML, Frassine F, Baiguini A, Alghisi A, Tomasini D, Borghetti P, Pasinetti N, Bresciani R, Magrini SM, Buglione M. Mebendazole as a Candidate for Drug Repurposing in Oncology: An Extensive Review of Current Literature. Cancers (Basel). 2019 Aug 31;11(9):1284. doi: 10.3390/cancers11091284.
- Background: PubMed 35385794Hegazy SK, El-Azab GA, Zakaria F, Mostafa MF, El-Ghoneimy RA. Mebendazole; from an anti-parasitic drug to a promising candidate for drug repurposing in colorectal cancer. Life Sci. 2022 Jun 15;299:120536. doi: 10.1016/j.lfs.2022.120536. Epub 2022 Apr 3.
- Background: PubMed 8759664Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8.
- Background: PubMed 22856328Jena G, Trivedi PP, Sandala B. Oxidative stress in ulcerative colitis: an old concept but a new concern. Free Radic Res. 2012 Nov;46(11):1339-45. doi: 10.3109/10715762.2012.717692. Epub 2012 Sep 5.
- Background: PubMed 32913180Kobayashi T, Siegmund B, Le Berre C, Wei SC, Ferrante M, Shen B, Bernstein CN, Danese S, Peyrin-Biroulet L, Hibi T. Ulcerative colitis. Nat Rev Dis Primers. 2020 Sep 10;6(1):74. doi: 10.1038/s41572-020-0205-x.
- Background: PubMed 32703283Puente S, Lago M, Subirats M, Sanz-Esteban I, Arsuaga M, Vicente B, Alonso-Sardon M, Belhassen-Garcia M, Muro A. Imported Mansonella perstans infection in Spain. Infect Dis Poverty. 2020 Jul 23;9(1):105. doi: 10.1186/s40249-020-00729-9.
- Background: PubMed 30137278Sturm A, Maaser C, Calabrese E, Annese V, Fiorino G, Kucharzik T, Vavricka SR, Verstockt B, van Rheenen P, Tolan D, Taylor SA, Rimola J, Rieder F, Limdi JK, Laghi A, Krustins E, Kotze PG, Kopylov U, Katsanos K, Halligan S, Gordon H, Gonzalez Lama Y, Ellul P, Eliakim R, Castiglione F, Burisch J, Borralho Nunes P, Bettenworth D, Baumgart DC, Stoker J; European Crohn's and Colitis Organisation [ECCO] and the European Society of Gastrointestinal and Abdominal Radiology [ESGAR]. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 2: IBD scores and general principles and technical aspects. J Crohns Colitis. 2019 Mar 26;13(3):273-284. doi: 10.1093/ecco-jcc/jjy114. No abstract available.
- Background: PubMed 31423600Tolomeo M, Colomba C, Meli M, Cascio A. Hepatotoxicity caused by mebendazole in a patient with Gilbert's syndrome. J Clin Pharm Ther. 2019 Dec;44(6):985-987. doi: 10.1111/jcpt.13033. Epub 2019 Aug 18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mebendazole in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
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 1 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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 Egypt. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in disease activity (time frame: change in baseline). The study lists 2 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 NCT06335160, which also lists 15 linked publications.
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 6 Feb 2026.