A Phase 1b, Multicentre, Open Label, Study of the Efficacy, Safety and Tolerability of R131 Ointment in Women with Cytological Abnormalities of the Uterine Cervix

Inclusion Criteria26

• Provision of written informed consent prior to any study specific procedures;
• Female participants aged 22-50 years inclusive at the time of screening visit;
• Positive result for cervical high-risk HPV (types 16, 18 or other);
• High-grade cytological abnormalities of the uterine cervix defined as HSIL/CIN 2 and above, confirmed by biopsy at Screening, or within 30 days prior to Screening visit,
• OR;
• low-grade cytological abnormalities of the uterine cervix defined as LSIL/ CIN1 as demonstrated by colposcopic biopsy collected at screening, or within 6 months prior to screening. Only collect biopsy sample if lesion is visible during colposcopic assessment. If no visible lesion, participant should be considered ineligible.
• Transformation zone needs to be fully visible;
• Generally, in good health with no clinically significant disease as determined by the investigator;
• Regular menstrual cycle with an approximate 28-day cycle;
• or women who are amenorrhoeic due to effective contraception (such as Mirena, Jadelle, or continuous COC)
• Agree to abstain from activities such as vaginal douching or insertion of any vaginal products other than the study drug for at least 48 hours prior to enrolment and throughout the study. Tampons or menstrual cups may be used during the participant’s menstrual cycle only.
• Women of childbearing potential (WOCBP) must use a highly effective form of birth control (confirmed by the Investigator). Rhythm methods will not be considered as highly effective methods of birth control. Highly effective forms of birth control include:
• True sexual abstinence (defined as refraining from heterosexual intercourse for the duration of the study and a minimum of 30 days following the last dose of study drug);
• Vasectomised partner (provided that the partner is the sole sexual partner of the female participant with childbearing potential and that the vasectomised partner has received medical assessment of the surgical success);
• Oral or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;
• Oral, injectable or implantable progestogen-only hormone contraception associated with inhibition of ovulation (Depo-Provera™, Implanon, Cerazette, Noriday (‘mini-pill’);
• Any effective intrauterine device/levonorgestrel intrauterine system;
• Female sterilisation by tubal occlusion;
• Evra Patch™
• WOCBP must agree to use a highly effective method of birth control, as defined above, from enrolment, and at least 14 days prior to Day 1, throughout the study duration and within 30 days after the last dose of IMP.
• WOCBP are defined as women who are neither permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), nor who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months or more without an alternative biological or medical cause e.g. contraceptive method such as Mirena.
• Male partners of female participants must agree to use condoms during sexual intercourse from the first dose of investigational product until 30 days after the participant’s last dose to avoid potential transfer of investigational product;
• Able and willing to abstain from sexual intercourse for 6 hours after dosing;
• Ability and willingness to attend the necessary visits to the clinical trial centre;
• Ability to comprehend all study related documentation, including written informed consent form, and complete all study-related tasks including daily diary;
• Be willing and able to adhere to the prohibitions and restrictions specified in the protocol