臨床研究等提出・公開システム

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326

Sex: FEMALE Age: CHILD, ADULTand OLDER ADULT - Oteseconazole (VT-1161): 217 Race: American Indian or Alaska Native: 1, Asian: 33, Black or African American: 26, White: 156, Unknown or Not Reported: 1 age: 34 (10.3) - Placebo: 109 Race: Asian: 12, Black or African American: 17, White: 80 Age: 34 (9.9)

-- Pre-assignment Details: A total of 438 subjects were enrolled in a 2-week Induction Phase after providing consent. During the Induction Phase, subjects received 3sequential 150mg of fluconazole administered 72 hours apart. Subjects whose presenting acute VVC (vulvovaginal candidiasis) episoderesolved during the Induction Phase (a total of 326) entered a 48-week Maintenance Phase comprised of a 12-week treatment period and a 36-week follow-up period. -- Arm/Group Title: Oteseconazole (VT-1161) - Description: 1 oteseconazole 150mg capsule once daily for 7 daysstarting at Day 1, then once weekly for 11 weeks - Completed: 182, Not Completed: 35 - Overall Number of Participants Analyzed: 217 (Measure Type: Number | Unit of Measure: percentage of subjects: 6.7) - Region of Enrollment Number Analyzed: 217 participants (United States: 85, Bulgaria: 50, Canada: 8, Japan: 32, Poland: 33, United Kingdom: 9) -- Arm/Group Title: Placebo - Description: 1 placebo capsule once daily for 7 days starting at Day 1,then once weekly for 11 weeks - Completed: 91, Not Completed: 18 - Overall Number of Participants Analyzed: 109 (Measure Type: Number | Unit of Measure: percentage of subjects: 42.8) - Region of Enrollment Number Analyzed: 109 participants (United States: 39, Bulgaria: 23, Canada: 8, Japan: 12, Poland: 24, United Kingdom: 3)

-- Adverse Event Reporting Description: The safety population was defined as all randomized subjects who received at least 1 dose of investigational product, which was not administered until Day 1. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. Adverse event data were not collected during the induction phase. -- Time Frame: Day 1 through Week 48 -- Other (Not Including Serious) Adverse Events_Frequency Threshold for Reporting Other Adverse Events: 2% -- Arm/Group Title: Oteseconazole (VT-1161) - All-Cause Mortality_Affected / at Risk (%): 0/217 (0.00%) - Serious Adverse Events_Affected / at Risk (%): Total 3/217 (1.38%) Infections and infestations Postoperative wound infection: 1/217 (0.46%) Tubo-ovarian abscess: 1/217 (0.46%) Injury, poisoning and procedural complications Limb traumatic amputation: 1/217 (0.46%) Respiratory, thoracic and mediastinal disorders Endometriosis: 1/217 (0.46%) -Other (Not Including Serious) Adverse Events_Affected / at Risk (%)_# Events: 129/217 (59.45%) Gastrointestinal disorders Nausea: 8/217 (3.69%) Diarrhoea: 8/217 (3.69%) Abdominal pain: 5/217 (2.30%) Abdominal pain lower: 4/217 (1.84%) Constipation: 2/217 (0.92%) General disorders Pyrexia: 5/217 (2.30%) Infections and infestations Nasopharyngitis: 26/217 (11.98%) Bacterial vaginosis: 14/217 (6.45%) Urinary tract infection: 12/217 (5.53%) Upper respiratory tract infection: 9/217 (4.15%) Sinusitis: 12/217 (5.53%) Cystitis: 4/217 (1.84%) Influenza: 7/217 (3.23%) Genital herpes: 7/217 (3.23%) Bronchitis: 4/217 (1.84%) Chlamydial infection: 4/217 (1.84%) Pharyngitis: 6/217 (2.76%) Vaginal infection: 1/217 (0.46%) Vulvovaginal candidiasis: 1/217 (0.46%) Injury, poisoning and procedural complications Procedural pain: 2/217 (0.92%) Investigations Blood creatine phosphokinase increased: 7/217 (3.23%) Musculoskeletal and connective tissue disorders Back pain: 3/217 (1.38%) Nervous system disorders Headache: 8/217 (3.69%) Psychiatric disorders Insomnia: 4/217 (1.84%) Reproductive system and breast disorders Vulvovaginal pruritus: 7/217 (3.23%) Metrorrhagia: 5/217 (2.30%) Menorrhagia: 4/217 (1.84%) Pelvic pain: 2/217 (0.92%) Vaginal discharge: 0/217 (0.00%) Skin and subcutaneous tissue disorders Acne: 5/217 (2.30%) Urticaria: 4/217 (1.84%) Rash: 0/217 (0.00%) -- Arm/Group Title: Placebo All-Cause Mortality_Affected / at Risk (%): 0/109 (0.00%) Serious Adverse Events_Affected / at Risk (%): Total 3/109 (2.75%) Infections and infestations Appendicitis: 1/109 (0.92%) Bronchitis: 1/109 (0.92%) Pneumonia: 1/109 (0.92%) Reproductive system and breast disorders Vaginal haemmorrhage: 1/109 (0.92%) Respiratory, thoracic and mediastinal disorders Acute respiratory failure: 1/109 (0.92%) Asthma: 1/109 (0.92%) -Other (Not Including Serious) Adverse Events_Affected / at Risk (%)_# Events: 63/109 (57.80%) Gastrointestinal disorders Nausea: 3/109 (2.75%) Diarrhoea: 2/109 (1.83%) Abdominal pain: 3/109 (2.75%) Abdominal pain lower: 1/109 (0.92%) Constipation: 2/109 (1.83%) General disorders Pyrexia: 4/109 (3.67%) Infections and infestations Nasopharyngitis: 7/109 (6.42%) Bacterial vaginosis: 11/109 (10.09%) Urinary tract infection: 7/109 (6.42%) Upper respiratory tract infection: 7/109 (6.42%) Sinusitis: 3/109 (2.75%) Cystitis: 8/109 (7.34%) Influenza: 1/109 (0.92%) Bronchitis: 2/109 (1.83%) Chlamydial infection: 2/109 (1.83%) Vaginal infection: 2/109 (1.83%) Vulvovaginal candidiasis: 2/109 (1.83%) Vulvitis: 2/109 (1.83%) Injury, poisoning and procedural complications Procedural pain: 2/109 (1.83%) Investigations Blood creatine phosphokinase increased: 3/109 (2.75%) Musculoskeletal and connective tissue disorders Back pain: 5/109 (4.59%) Nervous system disorders Headache: 8/109 (7.34%) Psychiatric disorders Insomnia: 1/109 (0.92%) Reproductive system and breast disorders Vulvovaginal pruritus: 2/109 (1.83%) Metrorrhagia: 3/109 (2.75%) Menorrhagia: 1/109 (0.92%) Pelvic pain: 2/109 (1.83%) Vaginal discharge: 4/109 (3.67%) Skin and subcutaneous tissue disorders Acne: 1/109 (0.92%) Urticaria: 1/109 (0.92%) Rash: 2/109 (1.83%)

Outcome Measures Percentage of Subjects With 1 or More Culture-Verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-Treat Population. Type: Primary | Time Frame: Maintenance phase (post-randomization through Week 48) Description: The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ?3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense) Analysis Population Description: Analysis was performed on the ITT population which included all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit. -- Arm/Group Title: Oteseconazole (VT-1161) Overall Number of Participants Analyzed: 217 Measure Type: Number | Unit of Measure: percentage of subjects: 6.7 -- Arm/Group Title: Placebo Overall Number of Participants Analyzed: 109 Measure Type: Number | Unit of Measure: percentage of subjects: 42.8

The primary efficacy outcome measure was the proportion of subjects with >=1 culture-verified acute VVC episode during the Maintenance Phase in the ITT Population. It was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of >=3. Scoring of VVC signs and symptoms was graded on a scale of 0 (none) to 3 (severe). Percentage of subjects with one or more acute VVC episodes during maintenance phase was oteseconazole 6.7% and placebo 42.8%

Yes

https://cdn.clinicaltrials.gov/large-docs/56/NCT03562156/Prot_000.pdf

jRCT IQVIA staffs

IQVIA Services Japan G.K.

4-10-18 Minatoku, Takanawa, Tokyo

Mycovia_CL011_JP_Registry@quintiles.com

jRCT IQVIA staffs

IQVIA Services Japan G.K.

4-10-18 Minatoku, Takanawa, Tokyo

+81-3-6859-9500

Mycovia_CL011_JP_Registry@quintiles.com

completed

Mar. 26, 2019

Interventional

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treatment purpose

3

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Female

v

investigational material(s)
Generic name etc :
INN of investigational material : Oteseconazole
Therapeutic category code : 629 Other chemotherapeutics
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

efficacy

other

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Dec. 18, 2018