A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail

NCT04188574 | Completed Phase 2 FDA Drug

• 1 other identifier: BBTAF202
• Study Type: interventional
• Target: 111
• Locations: 3 countries
• Sites: 20

Brief Summary

This study will be a multicenter, international, randomized, vehicle-controlled, parallel-group, double-blinded study. Subjects who are eligible to participate with a confirmed diagnosis of Distal Subungual onychomycosis (DSO) of the toenail will be randomized and participate in one of the following treatment groups: BB2603-1: 0.01% terbinafine/0.03% polyhexanide formulation, or BB2603-3: 0.03% terbinafine/0.09% polyhexanide formulation, or BB2603-10: 0.1% terbinafine/0.3% polyhexanide formulation, or Vehicle: 0.3% polyhexanide/20% ethanol/water formulation. The subject in each treatment group will be treated twice daily (BID) for 12 weeks and then complete a 28-day post-treatment visit.

Conditions

Distal Subungual Onychomycosis; Fungal Infection; Fungus, Nail

Keywords

DSO; Fungual Infection; Fungus, Nail

Outcome Measures

Primary Outcomes (1)

• Number of subjects with an Early Response for BB2603-10 versus vehicle

  Early Response is defined as clinimetrically assessed clear nail growth (yes/no) and/or negative dermatophyte culture (yes/no).

  16 weeks

Secondary Outcomes (7)

• Number of subjects with a Complete Cure for BB2603-10 versus vehicle

  52 weeks

• Number of subjects with Completely Clear Nail, Almost Clear Nail, Negative KOH or Negative Dermatocyte Culture, assessed separately, for BB2603-10 versus vehicle

  52 weeks

• Concentration of terbinafine in the plasma in all subjects

  52 weeks

• Number of subjects with adverse events

  16, 24, 28 weeks

• Number of subjects with an Early Response for BB2603-1 or BB2603-3, respectively versus vehicle

  16 weeks

Study Arms (4)

BB2603-10

EXPERIMENTAL

Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine

Drug: BB2603-10; Other: Vehicle

BB2603-3

EXPERIMENTAL

Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine

Drug: BB2603-3; Other: Vehicle

BB2603-1

EXPERIMENTAL

Treatment with topical spray twice-daily (BID)BB2603-1: 0.01% terbinafine

Drug: BB2603-1; Other: Vehicle

Vehicle Control

OTHER

0.3% polyhexanide/ 20% ethanol/ water formulation.

Drug: BB2603-1; Drug: BB2603-3; Drug: BB2603-10; Other: Vehicle

Interventions

BB2603-1 DRUG

Treatment with topical spray twice-daily (BID) BB2603-1: 0.01% terbinafine

BB2603-1; Vehicle Control

BB2603-3 DRUG

Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine

BB2603-3; Vehicle Control

BB2603-10 DRUG

Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine

BB2603-10; Vehicle Control

Vehicle OTHER

Treatment with topical spray twice-daily (BID): 0.3% polyhexanide/ 20% ethanol/ water formulation.

BB2603-1; BB2603-10; BB2603-3; Vehicle Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 (and ≤99) at the time of Informed Consent.
• Clinically and mycologically (KOH and culture positive for dermatophytes \[microbial infection with fungus belonging to the genus Trichophyton, Microsporum, Epidermophyton\]) confirmed diagnoses of DSO of the target toenail affecting ≥25% to ≤60% of the target toenail as determined through clinimetric measurement.
• Signed written informed consent form (ICF) prior to any trial related activity (subjects must have the mental, literate, and legal ability to give a written informed consent, which must comply with the ICH GCP guidelines and local requirements).
• Subjects must be willing and able to comply with trial requirements.
• Females must be either postmenopausal for ≥1 year (ie 12 consecutive months of amenorrhea, for which there is no other obvious pathologic or physiologic cause), or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months or, if of childbearing potential must use either highly effective birth control methods such as:
• Oral, intravaginal or transdermal oestrogen- and progestogen-containing hormonal contraception associated with inhibition of ovulation
• Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
• Intrauterine device or intrauterine hormone-releasing system
• Bilateral tubal occlusion
• Vasectomised partner provided that the partner is the sole sexual partner and that the vasectomised partner has received medical assessment of the surgical success Clinical Study Protocol
• Sexual abstinence, ie, refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments
• Acceptable birth control methods such as:
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
• Male or female condom with or without spermicide
• Cap, diaphragm or sponge with spermicide

You may not qualify if:

• Any other form of OM except DSO.
• Nails with clinical evidence of no or low distal growth.
• DSO of the target toenail where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is ≤3mm) or nail matrix. Any severe OM defined as 3 or more affected toes on one foot.
• Estimated target toenail thickness \>3mm.
• Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
• History of dermatophyte infections unresponsive to systemic or topical anti-fungal drugs (other than OM).
• Presence of toenail infection that does not involve a dermatophyte.
• Presence of toenail infection that involves a non-dermatophyte fungus or yeast in combination with a dermatophyte, where the non-dermatophyte is, in the opinion of the Investigator, considered to be causative of OM based on clinical appearance, medical history or lifestyle risk.
• Topical treatment with an antifungal medication within 12 weeks before Randomisation/Visit 2 (with the exception of up to 2 weeks' treatment during the screening period with a non-terbinafine topical antifungal to treat clinically active TP).
• Systemic use of anti-fungal treatment within 12 months before Randomisation/Visit 2.
• Past use within the last 6 months before Randomisation/Visit 2 or planned use of laser therapy, photodynamic therapy, chemical, surgical, relevant mechanical removal for OM or debridement.
• Concomitant clinically suspected active TP at Randomisation/Visit 2.
• Known allergy or known intolerabilities to any of the tested treatment products.
• Subjects with diabetes, immune suppression, peripheral vascular disease, lymphatic insufficiency, recurrent cellulitis, or other compromised states of health whether due to underlying medical disorders or to long-term immunosuppressive treatments (including \>4 weeks systemic corticoids or \>4 weeks topical corticoids on the feet). Topical immunosuppressive treatment if not on the target nail is allowed.
• Females of childbearing potential with a positive serum pregnancy test at Screening/Visit 1 and/or a positive urine pregnancy test at Randomisation/Visit 2 are excluded.

Sponsors & Collaborators

• Blueberry Therapeutics: lead
• IQVIA Biotech: collaborator

Study Sites (20)

Dermatovenerologická klinika VFN

Prague, Czechia

Location

Sanatorium prof. Arenbergera

Prague, Czechia

Location

Licca Clinical Research Institute

Augsburg, Germany

Location

Praxis Dr. med. Thomas Wildfeuer & Kolleg*innen

Berlin, Germany

Location

Hautzentrum Jahrhunderthaus Gemeinschaftspraxis Dres. Niesmann und Othlinghaus

Bochum, Germany

Location

Uniklink Carl Gustav Carus, Klinik und Polyklinik für Dermatologie

Dresden, Germany

Location

Hautarztpraxis Dres. Leitz

Stuttgart, Germany

Location

Centroderm GmbH

Wuppertal, Germany

Location

NZOZ Dermal

Bialystok, Poland

Location

NZOZ Osteo-Medic

Bialystok, Poland

Location

Klinika Dermatologii, Wenerologii

Gdansk, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Poland

Location

Gyncentrum Osrodek Badan Klinicznych

Katowice, Poland

Location

ETG Lodz

Lodz, Poland

Location

Etg Lublin Kunickiego

Lublin, Poland

Location

ETG Siedlce

Siedlce, Poland

Location

Laser Clinic

Szczecin, Poland

Location

ETG Warszawa

Warsaw, Poland

Location

dermMedica

Wroclaw, Poland

Location

ETG Zamość

Zamość, Poland

Location

MeSH Terms

Conditions

Mycoses; Onychomycosis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Tinea; Dermatomycoses; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Treatment allocation will not be disclosed to the site team or subject or the clinical Sponsor team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blinded

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: December 6, 2019
• Study Start: March 22, 2021
• Primary Completion: December 6, 2022
• Study Completion: June 28, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (12); CZ (2); DE (6)