Adenomatous Polyposis ColiPhase 1NCT03649971
A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
A Phase 1 study testing Guselkumab in people with Adenomatous Polyposis Coli, run by Janssen Research & Development, LLC at 32 sites in 9 countries.
Trial summary
The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenomatous Polyposis Coli
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 19 Nov 2018to 23 Mar 2022
- Phase
- 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
- Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than (>)100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed
- Post-colectomy or subtotal colectomy
- Polyps with a sum of diameters greater than or equal to (>=)10 millimeter (mm) in the rectum or pouch on biopsy at screening
- A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration
- A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last administration of study drug
Who cannot join
- Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor
- Use of non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 100 milligram (mg) of aspirin a day or 700 mg of aspirin per week is allowed
- Treatment with other FAP-directed drug therapy (including NSAID [Nonsteroidal anti-inflammatory drug] drugs), unless completes a 4-week washout period prior to randomization
- High grade dysplasia or cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch)
- Duodenal, colorectal, or pouch polyp: >2 centimeter (cm) unless excised at the screening evaluation; and 1 to 2 cm with evidence of high-grade dysplasia upon biopsy unless excised
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
United States18 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
Wexner Medical Center at the Ohio State University
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06519
Ochsner Medical Center
New Orleans, Louisiana, 70121
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Phoenix, Arizona, 85054
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84132
University of Washington
Seattle, Washington, 98195
Washington University School Of Medicine
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Netherlands3 sites
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 1105 AZ
Leiden University Medical Center
Leiden, 2333 ZA
Erasmus MC
Rotterdam, 3015 GD
France2 sites
Hopital Edouard Herriot - CHU Lyon
Lyon, 69437
APHM Hopital Timone
Marseille, 13385
Germany2 sites
Universitatsklinikum Bonn
Bonn, 53127
Universitatsklinikum Ulm
Ulm, 89070
Poland2 sites
Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Po
Poznan, 60 355
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
Spain2 sites
Hosp Univ Vall D Hebron
Barcelona, 8035
Hosp Clinic de Barcelona
Barcelona, 8036
Puerto Rico1 site
Pan American Center for Oncology Trials LLC
Rio Piedras, 00935
About this study
Official title: A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis
The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.
Read the detailed description
Familial adenomatous polyposis (FAP) is the most common polyposis syndrome. It is autosomal dominant inherited disorder characterized by early onset of hundreds to thousands of adenomatous polyps throughout colon. If left untreated, this syndrome may develop colorectal cancer (CRC). Polyps from individuals with FAP display inflammatory features associated with activation of interleukin (IL) 23/IL 17/JAK/STAT3 pathway. This inflammation is thought to contribute to further mutagenesis, culminating in tumor development. Specifically, IL-23 is linked to tumor growth and progression in CRC. Guselkumab is a human immunoglobulin monoclonal antibody directed against p19 subunit of IL-23, specifically targets IL-23 and inhibits its interaction with IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent cell activation and cytokine production, which result in less inflammation and reduce tumor development. The clinical hypothesis of this study is that treatment with guselkumab will reduce rectal/pouch polyp burden compared with baseline in active arms compared with placebo. The study is designed to determine if guselkumab has clinical activity in colorectum and duodenum, by reducing number of polyps over a period of 24 weeks. Participants will be randomized to 1 of 3 treatment arms (Guselkumab 100 mg [milligram] SC [subcutaneous], Guselkumab 300 mg SC, and placebo SC). Efficacy evaluations include rectal/pouch polyp burden assessment, biomarker analysis include discrete IL-23 signaling effector proteins (IL-23R, pSTAT3, Il-17A) and safety evaluations will include monitoring of adverse events, laboratory tests, vital sign measurements, and physical examination. Safety will be monitored throughout study (up to Week 60).
- Conditions
- Adenomatous Polyposis Coli
- Being tested
- Guselkumab, Placebo
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called Tremfya
Guselkumab SC will be administered every 4 weeks.
PlaceboDrug
Placebo SC will be administered every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab Dose 1 | Experimental | Participants will receive guselkumab Dose 1 subcutaneous (SC), 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48. Receives: Drug: Guselkumab |
| Guselkumab Dose 2 | Experimental | Participants will receive guselkumab Dose 2 SC, 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48. Receives: Drug: Guselkumab |
| Placebo | Placebo comparator | Participants will receive placebo SC, 6 doses every 4 weeks from Week 0 to Week 20. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24
Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy.
Measured: Baseline, Week 24
Secondary outcomes (14)
Percentage Change from Baseline in Number of Colorectal Polyps
Percentage change from baseline in number of colorectal polyps will be determined.
Measured: Baseline, Weeks 24 and 52
Percentage Change from Baseline in Number of J-pouch Polyps
Percentage change from baseline in number of J-pouch polyps will be determined.
Measured: Baseline, Weeks 24 and 52
Percentage Change from Baseline in J-pouch Polyp Burden
Percentage change from baseline in J-pouch polyp burden (sum of polyp diameters) will be determined.
Measured: Baseline, Weeks 24 and 52
Percentage Change from Baseline in Number of Duodenal Polyps
Percentage change from baseline in number of duodenal polyps will be determined.
Measured: Baseline, Weeks 24 and 52
Percentage Change from Baseline in Duodenal Polyp Burden
Percentage change from baseline in duodenal polyp burden (sum of polyp diameters) will be determined.
Measured: Baseline, Weeks 24 and 52
Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Stage
Change in InSiGHT stage will be determined. Various stages of InSiGHT staging system are defined as: Stage 0: 0-10 polyps, all less than (<)5 millimeter (mm); Stage 1: 10-25 polyps, most < 5 mm, none greater than (>) 1 centimeter (cm); Stage 2: 10-25 polyps, any > 1 cm, amenable to complete removal; Stage 3: > 25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of High-Grade Dysplasia (HGD), even if completely excised; and Stage 4: > 25 polyps amenable to complete removal, or any incompletely excised sessile polyp showing HGD, any invasive cancer).
Measured: Baseline, Weeks 24 and 52
Change in Spigelman Stage Score
Change in Spigelman stage score will be determined. Spigelman classification system measures risk of developing duodenal cancer in familial adenomatous polyposis (FAP). It has been classified in following stages- Stage 0 (0 points); Stage 1 (1-4 points); Stage 2 (5-6 points); Stage 3 (7-8 points); and Stage 4 (9-12 points). The total score ranges from 0 to 12. Points are accumulated for polyps' number, size, histology and severity of dysplasia. Stage 1 indicates mild disease, whereas stage 3-4 indicates severe duodenal polyposis.
Measured: Baseline, Weeks 24 and 52
Trough Concentration of Guselkumab
Serum samples will be analyzed to determine trough concentrations of guselkumab using a validated specific, and sensitive method.
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Number of Participants with Anti-guselkumab Antibodies
Number of participants with Anti-guselkumab antibodies will be determined.
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Anti-guselkumab Antibodies Serum Titers
Serum samples will be screened for antibodies binding to guselkumab and the titer of confirmed positive samples will be reported.
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Number of Participants with Adverse Events as a Measure of Safety
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: From Screening up to 60 Weeks
Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability
Number of participants with vital sign abnormalities will be reported. Vital signs includes temperature, pulse/heart rate, respiratory rate and blood pressure.
Measured: From Screening up to 52 Weeks
Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
Number of participants with clinical laboratory abnormalities will be reported. Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
Measured: From Screening up to 52 Weeks
Relative Changes to Baseline in Levels of Interleukin (IL)-23 Effector Proteins in Biopsy Tissue
Relative Changes to Baseline in levels of IL-23 effector proteins in biopsy tissue will be measured.
Measured: Baseline, Weeks 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start19 Nov 2018
- Primary completion13 Sep 2021
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenomatous Polyposis ColiStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649971
- Sponsor's protocol ID
- CR108515
- Other IDs
- CNTO1959COR1001, 2019-001980-57, 2019
- Status last verified
- Jan 2025
- First submitted
- 27 Aug 2018
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Stone JK, Mehta NA, Singh H, El-Matary W, Bernstein CN. Endoscopic and chemopreventive management of familial adenomatous polyposis syndrome. Fam Cancer. 2023 Oct;22(4):413-422. doi: 10.1007/s10689-023-00334-3. Epub 2023 Apr 29.
PubMed 37119510
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT03649971
- Acronym / sponsor ID
- CR108515
- Conditions
- Adenomatous Polyposis Coli
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 28 Aug 2018 (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 purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.
Detailed description
Familial adenomatous polyposis (FAP) is the most common polyposis syndrome. It is autosomal dominant inherited disorder characterized by early onset of hundreds to thousands of adenomatous polyps throughout colon. If left untreated, this syndrome may develop colorectal cancer (CRC). Polyps from individuals with FAP display inflammatory features associated with activation of interleukin (IL) 23/IL 17/JAK/STAT3 pathway. This inflammation is thought to contribute to further mutagenesis, culminating in tumor development. Specifically, IL-23 is linked to tumor growth and progression in CRC. Guselkumab is a human immunoglobulin monoclonal antibody directed against p19 subunit of IL-23, specifically targets IL-23 and inhibits its interaction with IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent cell activation and cytokine production, which result in less inflammation and reduce tumor development. The clinical hypothesis of this study is that treatment with guselkumab will reduce rectal/pouch polyp burden compared with baseline in active arms compared with placebo. The study is designed to determine if guselkumab has clinical activity in colorectum and duodenum, by reducing number of polyps over a period of 24 weeks. Participants will be randomized to 1 of 3 treatment arms (Guselkumab 100 mg [milligram] SC [subcutaneous], Guselkumab 300 mg SC, and placebo SC). Efficacy evaluations include rectal/pouch polyp burden assessment, biomarker analysis include discrete IL-23 signaling effector proteins (IL-23R, pSTAT3, Il-17A) and safety evaluations will include monitoring of adverse events, laboratory tests, vital sign measurements, and physical examination. Safety will be monitored throughout study (up to Week 60).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guselkumab Dose 1 | Experimental | Drug: GuselkumabParticipants will receive guselkumab Dose 1 subcutaneous (SC), 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48. |
| Guselkumab Dose 2 | Experimental | Drug: GuselkumabParticipants will receive guselkumab Dose 2 SC, 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC, 6 doses every 4 weeks from Week 0 to Week 20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than (>)100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed
- Post-colectomy or subtotal colectomy
- Polyps with a sum of diameters greater than or equal to (>=)10 millimeter (mm) in the rectum or pouch on biopsy at screening
- A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration
- A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last administration of study drug
Key exclusion criteria (5 listed)
- Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor
- Use of non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 100 milligram (mg) of aspirin a day or 700 mg of aspirin per week is allowed
- Treatment with other FAP-directed drug therapy (including NSAID [Nonsteroidal anti-inflammatory drug] drugs), unless completes a 4-week washout period prior to randomization
- High grade dysplasia or cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch)
- Duodenal, colorectal, or pouch polyp: >2 centimeter (cm) unless excised at the screening evaluation; and 1 to 2 cm with evidence of high-grade dysplasia upon biopsy unless excised
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 |
|---|---|---|
| GuselkumabAlso: TremfyaGuselkumab SC will be administered every 4 weeks. | Drug | Guselkumab Dose 1, Guselkumab Dose 2 |
| PlaceboPlacebo SC will be administered every 4 weeks. | Drug | Placebo |
Primary outcome
Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24
Time frame: Baseline, Week 24
Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy.
14 secondary outcomes
Percentage Change from Baseline in Number of Colorectal Polyps
Time frame: Baseline, Weeks 24 and 52
Percentage Change from Baseline in Number of J-pouch Polyps
Time frame: Baseline, Weeks 24 and 52
Percentage Change from Baseline in J-pouch Polyp Burden
Time frame: Baseline, Weeks 24 and 52
Percentage Change from Baseline in Number of Duodenal Polyps
Time frame: Baseline, Weeks 24 and 52
Percentage Change from Baseline in Duodenal Polyp Burden
Time frame: Baseline, Weeks 24 and 52
Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Stage
Time frame: Baseline, Weeks 24 and 52
Change in Spigelman Stage Score
Time frame: Baseline, Weeks 24 and 52
Trough Concentration of Guselkumab
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Number of Participants with Anti-guselkumab Antibodies
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Anti-guselkumab Antibodies Serum Titers
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Number of Participants with Adverse Events as a Measure of Safety
Time frame: From Screening up to 60 Weeks
Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability
Time frame: From Screening up to 52 Weeks
Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
Time frame: From Screening up to 52 Weeks
Relative Changes to Baseline in Levels of Interleukin (IL)-23 Effector Proteins in Biopsy Tissue
Time frame: Baseline, Weeks 12, 24, and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 37119510Stone JK, Mehta NA, Singh H, El-Matary W, Bernstein CN. Endoscopic and chemopreventive management of familial adenomatous polyposis syndrome. Fam Cancer. 2023 Oct;22(4):413-422. doi: 10.1007/s10689-023-00334-3. Epub 2023 Apr 29.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Guselkumab in people with Adenomatous Polyposis Coli, run by Janssen Research & Development, LLC at 32 sites in 9 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 5 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Netherlands, France, Germany, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24 (time frame: Baseline, Week 24). 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 NCT03649971, which also lists 1 linked publication.
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 3 Feb 2025.