HSIL, High Grade Squamous Intraepithelial Lesion study: EXE-346 Probiotic
Official title CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
ClinicalTrials.gov ID: NCT06949800
What this study is testing
What is EXE-346 Probiotic?
EXE-346 Probiotic is an investigational medicine, being studied as a potential treatment for hsil, high grade squamous intraepithelial lesion.
Also referred to as EXE-346 Probiotic formula, Probiotic.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Signed informed consent
- Of non-childbearing potential (i.e. persons aged 60 years or older or who have had a hysterectomy or tubal ligation or are postmenopausal, as defined...
- Persons aged less than 60 years of childbearing potential and agree to practice highly effective contraception from initiation of taking EXE-346 or...
You likely can't join if
- History of any anogenital cancer.
- History of inflammatory bowel disease
- Presence of untreated cervical HSIL or cervical cancer.
- Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.
- Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit...
- Use of high dose corticosteroids (\>10 mg/day prednisone or equivalent) for \>=7 days (inhaled, otic, topical and ophthalmic corticosteroids are...
See the full eligibility criteria
- Signed informed consent
- Of non-childbearing potential (i.e. persons aged 60 years or older or who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative...
- Persons aged less than 60 years of childbearing potential and agree to practice highly effective contraception from initiation of taking EXE-346 or placebo through 14 days after taking the last dose of EXE-346 or...
- History of any anogenital cancer.
- History of inflammatory bowel disease
- Presence of untreated cervical HSIL or cervical cancer.
- Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.
- Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit for ULACNet-102.
- Use of high dose corticosteroids (\>10 mg/day prednisone or equivalent) for \>=7 days (inhaled, otic, topical and ophthalmic corticosteroids are permitted).
- Primary immune deficiency disease.
- Use of synthetic or biologic disease-modifying anti-rheumatic drugs.
- History of bone marrow or solid organ transplant.
- History of any other clinically significant autoimmune or immunosuppressive disease.
- Participant initiated a new treatment with antibiotics within the 2 weeks prior to screening or plans to start antibiotic therapy during the study period.
- Participant is taking NSAIDs as a long-term treatment (ie, consistent use for at least 4 days/week each month). Acute use of NSAIDs is allowed.
- Participant has known hypersensitivity to EXE-346 or any product components.
- Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Warts so extensive that they preclude the clinician from determining the extent and location of HSIL.
- Sustained, manually confirmed, sitting systolic blood pressure \>150 mm Hg or \ 95 mm Hg as measured by 3 readings taken 15 minutes apart at screening or Visit 1.
- History of significant thrombocytopenia, history of thrombosis with thrombocytopenia (TTS) syndrome or heparin-induced thrombocytopenia.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance...
- Use of probiotics other than EXE-346 during the study and for a period of two weeks prior to screening.
- Participant has participated in any clinical study of an approved or unapproved investigational medicinal product within the 30 days prior to screening.
- Any other finding that, in the opinion of the Investigator deems the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.