Ankylosing SpondylitisEarly Phase 1FUNNCT05119712
Terbinafine Treatment of Axial Spondyloarthropathy
A Early Phase 1 study testing Terbinafine Tablets and Laboratory Testing in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Axial Spondyloarthritis, Psoriatic Spondylitis
- What is being tested?
- Terbinafine Tablets and Laboratory Testing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 15 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 and older of either sex will be included.
- Subjects must be willing and able to provide informed consent.
- Subjects must have been diagnosed with ankylosing spondylitis, axial spondyloarthritis, psoriatic spondylitis or spondylitis secondary to inflammatory bowel disease by a physician and must be willing to request records to validate the diagnosis.
- Subjects must complete a symptom questionnaire called a BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and must have a score of four or above to indicate active disease and the potential to improve.
- Subjects must agree to remain on a stable treatment regimen for their joint disease for the duration of the trial and for one month before the study begins.
- Subjects must be willing to provide stool samples and be willing to have routine lab studies every 8 weeks during the duration of the study.
Who cannot join
- Pregnant or lactating women will not be included.
- Subjects must not be allergic or intolerant to terbinafine.
- Subjects must not be taking medications that have the potential for serious interactions with terbinafine. These drugs include desipramine, cimetidine, fluconazole, cyclosporine and rifampin.
- Subjects must not have taken antibiotics within 3 months of starting the study drug and collecting the baseline stool specimen.
- Subjects with the following blood dyscrasias will not be included:
- Hemoglobin <9g/dL or Hematocrit <30% White blood cell count <3.0 K/cu mm Absolute neutrophil count <1.2 K/cu mm Platelet count <100 K/cu mm Subjects with an estimated GFR ≤50 ml/min Subjects with a total bilirubin, AST, or ALT more than 1.5 times the upper limit of normal at screening.
Show all 12Show fewer
- Severe, progressive, or uncontrolled chronic liver disease including fibrosis, cirrhosis, or recent or active hepatitis.
- History of any lymphoproliferative disorder such as Epstein Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggest of current lymphatic disease.
- Current malignancy or history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- Have a known infection with human immunodeficiency virus (HIV)
- Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac (New York Heart Association class III or IV), neurologic, or cerebral diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy
Read the detailed description
The purpose of this trial is to determine if terbinafine is an effective therapy for ankylosing spondylitis. Benefit will be determined by a reduction of the BASDAI by two or more.
The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.
- Conditions
- Ankylosing Spondylitis, Axial Spondyloarthritis, Psoriatic Spondylitis, Spondylitis Secondary to Inflammatory Bowel Disease, Axial Spondyloarthopathy
- Being tested
- Terbinafine Tablets, Laboratory Testing
- Keywords
- fungus, malassezia, microbiome
- Medical subject headings
- Spondylitis, Ankylosing, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine TabletsDrug
Also called Lamisil
500mg oral terbinafine or placebo daily
Laboratory TestingDiagnostic test
Also called Blood work
Laboratory testing at screening, baseline, week 8, 16, 24 and 32.
Laboratory TestingDiagnostic test
Also called Urinalysis
Subjects with the potential to become pregnant will have a baseline urine pregnancy test prior to starting study drug.
| Study group | Role | What they receive |
|---|---|---|
| Placebo to Drug | Active comparator | Subjects will begin treatment on placebo then crossover to study drug. Receives: Drug: Terbinafine Tablets; Diagnostic Test: Laboratory Testing |
| Drug to Placebo | Active comparator | Subjects will begin treatment on study drug then crossover to placebo. Receives: Drug: Terbinafine Tablets; Diagnostic Test: Laboratory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BASDAI score
BASDAI score after the completion of 16 weeks of terbinafine treatment versus the BASDAI score after 16 weeks on placebo. Benefit is defined by a reduction of BASDAI score of 2 or more.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start9 Mar 2021
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Oct 2024 (estimated)
Why it stopped: Study stopped due to poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will receive either terbinafine 500 mg or placebo for 16 weeks and then crossed over to the opposite therapy for another 16 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- The Malassezia Foundation
- Responsible party
- Principal investigator, Atul Deodhar, Oregon Health and Science University
- Investigators
- Atul Deodhar, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119712
- Sponsor's protocol ID
- STUDY00021565
- Acronym
- FUN
- Status last verified
- Aug 2023
- First submitted
- 3 Nov 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Publications
Reveille JD, Witter JP, Weisman MH. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012 Jun;64(6):905-10. doi: 10.1002/acr.21621. Epub 2012 Jan 24.
PubMed 22275150Goie The HS, Steven MM, van der Linden SM, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis: a comparison of the Rome, New York and modified New York criteria in patients with a positive clinical history screening test for ankylosing spondylitis. Br J Rheumatol. 1985 Aug;24(3):242-9. doi: 10.1093/rheumatology/24.3.242.
PubMed 3160423Asquith M, Rosenbaum JT. The interaction between host genetics and the microbiome in the pathogenesis of spondyloarthropathies. Curr Opin Rheumatol. 2016 Jul;28(4):405-12. doi: 10.1097/BOR.0000000000000299.
PubMed 27152700Laurence M, Asquith M, Rosenbaum JT. Spondyloarthritis, Acute Anterior Uveitis, and Fungi: Updating the Catterall-King Hypothesis. Front Med (Lausanne). 2018 Apr 5;5:80. doi: 10.3389/fmed.2018.00080. eCollection 2018.
PubMed 29675414Mielants H, Veys EM, De Vos M, Cuvelier C, Goemaere S, De Clercq L, Schatteman L, Elewaut D. The evolution of spondyloarthropathies in relation to gut histology. I. Clinical aspects. J Rheumatol. 1995 Dec;22(12):2266-72.
PubMed 8835560Maillet J, Ottaviani S, Tubach F, Roy C, Nicaise-Rolland P, Palazzo E, Dieude P. Anti-Saccharomyces cerevisiae antibodies (ASCA) in spondyloarthritis: Prevalence and associated phenotype. Joint Bone Spine. 2016 Dec;83(6):665-668. doi: 10.1016/j.jbspin.2015.10.011. Epub 2016 Mar 15.
PubMed 26992953Gross O, Gewies A, Finger K, Schafer M, Sparwasser T, Peschel C, Forster I, Ruland J. Card9 controls a non-TLR signalling pathway for innate anti-fungal immunity. Nature. 2006 Aug 10;442(7103):651-6. doi: 10.1038/nature04926. Epub 2006 Jul 12.
PubMed 16862125Zhernakova A, Festen EM, Franke L, Trynka G, van Diemen CC, Monsuur AJ, Bevova M, Nijmeijer RM, van 't Slot R, Heijmans R, Boezen HM, van Heel DA, van Bodegraven AA, Stokkers PC, Wijmenga C, Crusius JB, Weersma RK. Genetic analysis of innate immunity in Crohn's disease and ulcerative colitis identifies two susceptibility loci harboring CARD9 and IL18RAP. Am J Hum Genet. 2008 May;82(5):1202-10. doi: 10.1016/j.ajhg.2008.03.016. Epub 2008 Apr 24.
PubMed 18439550Pointon JJ, Harvey D, Karaderi T, Appleton LH, Farrar C, Stone MA, Sturrock RD, Brown MA, Wordsworth BP. Elucidating the chromosome 9 association with AS; CARD9 is a candidate gene. Genes Immun. 2010 Sep;11(6):490-6. doi: 10.1038/gene.2010.17. Epub 2010 May 13.
PubMed 20463747Ruutu M, Thomas G, Steck R, Degli-Esposti MA, Zinkernagel MS, Alexander K, Velasco J, Strutton G, Tran A, Benham H, Rehaume L, Wilson RJ, Kikly K, Davies J, Pettit AR, Brown MA, McGuckin MA, Thomas R. beta-glucan triggers spondylarthritis and Crohn's disease-like ileitis in SKG mice. Arthritis Rheum. 2012 Jul;64(7):2211-22. doi: 10.1002/art.34423.
PubMed 22328069Takahata Y, Sugita T, Hiruma M, Muto M. Quantitative analysis of Malassezia in the scale of patients with psoriasis using a real-time polymerase chain reaction assay. Br J Dermatol. 2007 Oct;157(4):670-3. doi: 10.1111/j.1365-2133.2007.08090.x. Epub 2007 Jul 19.
PubMed 17634085Limon JJ, Tang J, Li D, Wolf AJ, Michelsen KS, Funari V, Gargus M, Nguyen C, Sharma P, Maymi VI, Iliev ID, Skalski JH, Brown J, Landers C, Borneman J, Braun J, Targan SR, McGovern DPB, Underhill DM. Malassezia Is Associated with Crohn's Disease and Exacerbates Colitis in Mouse Models. Cell Host Microbe. 2019 Mar 13;25(3):377-388.e6. doi: 10.1016/j.chom.2019.01.007. Epub 2019 Mar 5.
PubMed 30850233Babu PR, Pravin AJS, Deshmukh G, Dhoot D, Samant A, Kotak B. Efficacy and Safety of Terbinafine 500 mg Once Daily in Patients with Dermatophytosis. Indian J Dermatol. 2017 Jul-Aug;62(4):395-399. doi: 10.4103/ijd.IJD_191_17.
PubMed 28794551Chapman SW, Pappas P, Kauffmann C, Smith EB, Dietze R, Tiraboschi-Foss N, Restrepo A, Bustamante AB, Opper C, Emady-Azar S, Bakshi R. Comparative evaluation of the efficacy and safety of two doses of terbinafine (500 and 1000 mg day(-1)) in the treatment of cutaneous or lymphocutaneous sporotrichosis. Mycoses. 2004 Feb;47(1-2):62-8. doi: 10.1046/j.1439-0507.2003.00953.x.
PubMed 14998402
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terbinafine Treatment of Axial Spondyloarthropathy
- ClinicalTrials.gov ID
- NCT05119712
- Acronym / sponsor ID
- FUN / STUDY00021565
- Conditions
- Ankylosing Spondylitis, Axial Spondyloarthritis, Psoriatic Spondylitis, Spondylitis Secondary to Inflammatory Bowel Disease, Axial Spondyloarthopathy
- Keywords
- fungus, malassezia, microbiome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to poor recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- The Malassezia Foundation
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 15 Nov 2021 (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.
This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy
Detailed description
The purpose of this trial is to determine if terbinafine is an effective therapy for ankylosing spondylitis. Benefit will be determined by a reduction of the BASDAI by two or more.
The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will receive either terbinafine 500 mg or placebo for 16 weeks and then crossed over to the opposite therapy for another 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Placebo to Drug | Active comparator | Drug: Terbinafine Tablets, Diagnostic Test: Laboratory TestingSubjects will begin treatment on placebo then crossover to study drug. |
| Drug to Placebo | Active comparator | Drug: Terbinafine Tablets, Diagnostic Test: Laboratory TestingSubjects will begin treatment on study drug then crossover to placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age 18 and older of either sex will be included.
- Subjects must be willing and able to provide informed consent.
- Subjects must have been diagnosed with ankylosing spondylitis, axial spondyloarthritis, psoriatic spondylitis or spondylitis secondary to inflammatory bowel disease by a physician and must be willing to request records to validate the diagnosis.
- Subjects must complete a symptom questionnaire called a BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and must have a score of four or above to indicate active disease and the potential to improve.
- Subjects must agree to remain on a stable treatment regimen for their joint disease for the duration of the trial and for one month before the study begins.
Key exclusion criteria (12 listed)
- Pregnant or lactating women will not be included.
- Subjects must not be allergic or intolerant to terbinafine.
- Subjects must not be taking medications that have the potential for serious interactions with terbinafine. These drugs include desipramine, cimetidine, fluconazole, cyclosporine and rifampin.
- Subjects must not have taken antibiotics within 3 months of starting the study drug and collecting the baseline stool specimen.
- Subjects with the following blood dyscrasias will not be included:
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 |
|---|---|---|
| Terbinafine TabletsAlso: Lamisil500mg oral terbinafine or placebo daily | Drug | Drug to Placebo, Placebo to Drug |
| Laboratory TestingAlso: Blood workLaboratory testing at screening, baseline, week 8, 16, 24 and 32. | Diagnostic test | Drug to Placebo, Placebo to Drug |
| Laboratory TestingAlso: UrinalysisSubjects with the potential to become pregnant will have a baseline urine pregnancy test prior to starting study drug. | Diagnostic test | Drug to Placebo, Placebo to Drug |
Primary outcome
Change in BASDAI score
Time frame: 16 weeks
BASDAI score after the completion of 16 weeks of terbinafine treatment versus the BASDAI score after 16 weeks on placebo. Benefit is defined by a reduction of BASDAI score of 2 or more.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Background: PubMed 22275150Reveille JD, Witter JP, Weisman MH. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012 Jun;64(6):905-10. doi: 10.1002/acr.21621. Epub 2012 Jan 24.
- Background: PubMed 3160423Goie The HS, Steven MM, van der Linden SM, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis: a comparison of the Rome, New York and modified New York criteria in patients with a positive clinical history screening test for ankylosing spondylitis. Br J Rheumatol. 1985 Aug;24(3):242-9. doi: 10.1093/rheumatology/24.3.242.
- Background: PubMed 27152700Asquith M, Rosenbaum JT. The interaction between host genetics and the microbiome in the pathogenesis of spondyloarthropathies. Curr Opin Rheumatol. 2016 Jul;28(4):405-12. doi: 10.1097/BOR.0000000000000299.
- Background: PubMed 29675414Laurence M, Asquith M, Rosenbaum JT. Spondyloarthritis, Acute Anterior Uveitis, and Fungi: Updating the Catterall-King Hypothesis. Front Med (Lausanne). 2018 Apr 5;5:80. doi: 10.3389/fmed.2018.00080. eCollection 2018.
- Background: PubMed 8835560Mielants H, Veys EM, De Vos M, Cuvelier C, Goemaere S, De Clercq L, Schatteman L, Elewaut D. The evolution of spondyloarthropathies in relation to gut histology. I. Clinical aspects. J Rheumatol. 1995 Dec;22(12):2266-72.
- Background: PubMed 26992953Maillet J, Ottaviani S, Tubach F, Roy C, Nicaise-Rolland P, Palazzo E, Dieude P. Anti-Saccharomyces cerevisiae antibodies (ASCA) in spondyloarthritis: Prevalence and associated phenotype. Joint Bone Spine. 2016 Dec;83(6):665-668. doi: 10.1016/j.jbspin.2015.10.011. Epub 2016 Mar 15.
- Background: PubMed 16862125Gross O, Gewies A, Finger K, Schafer M, Sparwasser T, Peschel C, Forster I, Ruland J. Card9 controls a non-TLR signalling pathway for innate anti-fungal immunity. Nature. 2006 Aug 10;442(7103):651-6. doi: 10.1038/nature04926. Epub 2006 Jul 12.
- Background: PubMed 18439550Zhernakova A, Festen EM, Franke L, Trynka G, van Diemen CC, Monsuur AJ, Bevova M, Nijmeijer RM, van 't Slot R, Heijmans R, Boezen HM, van Heel DA, van Bodegraven AA, Stokkers PC, Wijmenga C, Crusius JB, Weersma RK. Genetic analysis of innate immunity in Crohn's disease and ulcerative colitis identifies two susceptibility loci harboring CARD9 and IL18RAP. Am J Hum Genet. 2008 May;82(5):1202-10. doi: 10.1016/j.ajhg.2008.03.016. Epub 2008 Apr 24.
- Background: PubMed 20463747Pointon JJ, Harvey D, Karaderi T, Appleton LH, Farrar C, Stone MA, Sturrock RD, Brown MA, Wordsworth BP. Elucidating the chromosome 9 association with AS; CARD9 is a candidate gene. Genes Immun. 2010 Sep;11(6):490-6. doi: 10.1038/gene.2010.17. Epub 2010 May 13.
- Background: PubMed 22328069Ruutu M, Thomas G, Steck R, Degli-Esposti MA, Zinkernagel MS, Alexander K, Velasco J, Strutton G, Tran A, Benham H, Rehaume L, Wilson RJ, Kikly K, Davies J, Pettit AR, Brown MA, McGuckin MA, Thomas R. beta-glucan triggers spondylarthritis and Crohn's disease-like ileitis in SKG mice. Arthritis Rheum. 2012 Jul;64(7):2211-22. doi: 10.1002/art.34423.
- Background: PubMed 17634085Takahata Y, Sugita T, Hiruma M, Muto M. Quantitative analysis of Malassezia in the scale of patients with psoriasis using a real-time polymerase chain reaction assay. Br J Dermatol. 2007 Oct;157(4):670-3. doi: 10.1111/j.1365-2133.2007.08090.x. Epub 2007 Jul 19.
- Background: PubMed 30850233Limon JJ, Tang J, Li D, Wolf AJ, Michelsen KS, Funari V, Gargus M, Nguyen C, Sharma P, Maymi VI, Iliev ID, Skalski JH, Brown J, Landers C, Borneman J, Braun J, Targan SR, McGovern DPB, Underhill DM. Malassezia Is Associated with Crohn's Disease and Exacerbates Colitis in Mouse Models. Cell Host Microbe. 2019 Mar 13;25(3):377-388.e6. doi: 10.1016/j.chom.2019.01.007. Epub 2019 Mar 5.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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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.
Atul Deodhar, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Terbinafine Tablets and Laboratory Testing in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Oregon Health and Science University at 1 site in United States.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 28 Aug 2023. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in BASDAI score (time frame: 16 weeks). 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 NCT05119712, which also lists 14 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 28 Aug 2023.