A CLINICAL TRIAL TO ASSESS THE EFFECT OF FOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES IN PATIENTS WITH ONYCHOMYCOSIS
Scientific Title of Study
RANDOMIZED, DOUBLE BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED,
PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF
FOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES 169.1 MG OF DR.
REDDY’S LABORATORIES LIMITED WITH ITRACONAZOLE 200 MG IN
PATIENTS WITH ONYCHOMYCOSIS
DRL-IND-NDA04-FOS/2022 , Version 1.0 Dated 17 March 2022
Protocol Number
DRL-IND-NDA04-FOS/2022 Version 2.0; Dated: 11-October-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Piyush Agarwal
Designation
Head - Clinical Development & Clinical Strategy
Affiliation
Dr. Reddy’s Laboratories Limited
Address
Dr. Reddy’s Laboratories Limited
Global Clinical Management, IPDO, Innovation plaza, Bachupally village,Bachupally Mandal, Hyderabad, Medchal Malkajgiri District MedchalTELANGANA 500090 India
Dr. Reddy’s Laboratories Limited
Global Clinical Management, IPDO, Innovation plaza, Bachupally village,Bachupally Mandal, Hyderabad, Medchal Malkajgiri District MedchalTELANGANA 500090 India
Medchal TELANGANA 500090 India
Phone
Fax
Email
acgangaram@drreddys.com
Details of Contact Person Public Query
Name
Swarup Wani
Designation
Clinical Operation Manager
Affiliation
Dr. Reddy’s Laboratories Limited
Address
Dr. Reddy’s Laboratories Limited
Global Clinical Management, IPDO, Innovation plaza, Bachupally village,Bachupally Mandal, Hyderabad, Medchal Malkajgiri District MedchalTELANGANA 500090 India
Medchal TELANGANA 500090 India
Phone
Fax
Email
swarupwani@drreddys.com
Source of Monetary or Material Support
Dr. Reddys Laboratories Limited, Integrated Product Development, Innovation Plaza, SurveyNo 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal Malkajgiri District, Hyderabad500 090, Telangana, India
Sri Ramachandra Hospital Clinical Research Division, Dental college basement, No.1 Ramachandra nagar, Porur, Chennai-600116, Tamil Nadu, India Chennai TAMIL NADU
9444150373
srmcclinicalresearch@gmail.com
Dr Namita Narkhede
Supe Heart and Diabetes hospital and Research Center
Supe Heart and Diabetes hospital and Research CenterOpp Adhar Ashram Gharapure Ghat Rd near Rungta High School Ashok Stambh Raviwar Karanja Panchavati Nashik Maharashtra 42200 Nashik MAHARASHTRA
9022021807
namitanarkhede@yahoo.com
Dr Manjunath Shenoy M
Yenepoya Medical College hospital, Constituent College of Yenepoya (Deemed to be university),
Yenepoya Medical College hospital, Constituent College of Yenepoya (Deemed to be university), University road, Deralakatte, Mangalore 575018, Karnataka India Udupi KARNATAKA
Institutional Ethics Committee Osmania Medical College Hyderabad
Approved
Institutional Ethics Committee PGIMER Chandigarh
Approved
Integrity Ethics Committee CHL Hospital Indore
Approved
KD Hospital Institutional Ethics Committee
Approved
Lokmanya Medical Resaerch Centre
Approved
Sree Institutional Ethics Committe
Approved
Supe Hospital Ethics Committee
Approved
Yenepoya Ethics Committe 2
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fosravuconazole L-Lysine ethanolate Capsules
Test Arm: Patient in test arm will receive Fosravuconazole L-Lysine ethanolate Capsules 169.1mg; and 2 capsules of matching placebo of Itraconazole Once daily for 12 weeks
Comparator Agent
Itraconazole 200 mg
Comparator arm: Patient in comparator arm will receive Itraconazole 200 mg (2 capsules of 100 mg); and matching placebo of Fosravuconazole L-Lysine ethanolate Capsule once daily for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male and female subjects between 18 to 65 years of age.
2. Clinical diagnosis of Onychomycosis in atleast one great toenail confirmed by positive mycological culture and microscopic (KOH examination) findings for a dermatophyte. (If both great toenails meet inclusion criteria, the toenail with the greater involvement will be designated the target toenail).
3. Clinical involvement affecting 25% or more of the toenail
4. Willing to comply with protocol requirements and sign a statement of informed consent
5. Willing to refrain from using on the toenails topical products on the affected toenail and to which the subject has a high risk of developing an allergic reaction and/or dermatitis
6. Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period.
OR
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
OR
Postmenopausal for at least 1 year (at the time of screening)
ExclusionCriteria
Details
History of hypersensitivity or allergy to any of the study drugs or its components
2. Onychomycosis not caused by a dermatophyte (e.g. mold, candida spp. or bacterial infection etc.)
3. History of toenail surgery or any significant injury to the target toenail matrix
4. Significant nail thickening or deformity due to onychogryphosis or other conditions
5. Any systemic or dermatologic disorder, such as psoriasis, severe eczema, or severe atopic dermatitis which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
6. Presence of Superficial white, dystrophy or proximal involvement of the target nail onychomycosis or lichen planus.
7. Structural deformities of the target toenail or foot (eg, genetic or pigment disorders, chemical damage, tumors) that would interfere with treatment procedures or with assessments of efficacy, safety, or tolerability.
8. History or presence of ventricular dysfunction such as congestive heart failure (CHF), cardiac dysrhythmias, ischemic/valvular disease, COPD, peripheral edema, and pulmonary edema and any medical condition that in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol.
9. Uncontrollable diabetes mellitus with HbA1c ≥7%.
10. Female subjects who are Pregnant or lactating.
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level exceeding 2 times the upper limit of the normal range.
12. Receipt of any drug as part of a research study within 30 days prior to dosing.
13. Use within the previous 3 months or anticipated use during the study of any drugs that are known to affect the bioavailability of study drugs or are otherwise contraindicated to be taken with the study drugs.
14. Use of any oral or injectable antifungal agent or topical antifungal agent for nails within 36 weeks before the first administration of the study drug
15. Positive test result for HIV, HBV or HCV.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Percentage of patients with complete cure (mycological cure + clinical cure) at week 48.
At week 48
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Fosravuconazole L-Lysine ethanolate Capsules 169.1mg in comparison with Itraconazole 200 mg for in patients with Onychomycosis.
Percentage of patients with mycological /Complete/Clinical cure at week 12, 24, 36 and 48.
Percentage of patients with clinical cure (defined as investigator’s global assessment response of “cleared†or “excellentâ€) at week 12, 24, 36 and 48.
Relapse in terms of clinical (Clinical signs of infection determined at any time point subsequent to a clinical cure) or mycological relapse (Positive mycology determined at any time point subsequent to a mycological cure) by week 48
Target Sample Size
Total Sample Size="228" Sample Size from India="228" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
THE CLINICAL TRIAL IS RANDOMIZED, DOUBLE BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF FOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES 169.1 MG OF DR. REDDY’S LABORATORIES LIMITED WITH ITRACONAZOLE 200 MG IN PATIENTS WITH ONYCHOMYCOSIS. THE STUDY WILL BE CONDUCTED IN MULTICENTER ACROSS INDIA TO RECRUIT 228 SUBJECT FOR TRIAL