A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis

Status Terminated

Clinical Trial Summary

Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. There is a final follow up visit 2 weeks after.

Clinical Trial Description

Group 1 is an open-label safety cohort to determine the PK profile of the active study drug, BMX-010 ointment. At least 3 and up to 12 subjects will be enrolled to analyze the safety and pharmacokinetics of BMX-010 ointment. If a subject cannot complete the required PK blood draws, another subject will be enrolled to ensure at least 3 subjects complete the PK blood draws. Subjects will not be randomized and all subjects in this group will be dispensed BMX-010. Dispensing information will be provided by IWRS. Study drug will be administered in clinic on Day 1 and also Day 8 (the first study drug application of the day) in order to obtain pre-dose PK blood draws. Once a minimum of 3 subjects complete all of the PK blood draws (through Day 8) and the data is analyzed, the Clinical Safety Committee (CSC) will review and determine if enrollment to Group 2 can begin. Enrollment of subjects into Group 2 will not begin until the PK and safety data from a minimum of three subjects enrolled in Group 1 is obtained and analyzed, and proceeding with Group 2 has been approved by the sponsor. Once enrollment in Group 2 begins, the subjects will be randomized into Arm A, B, or C. Group 2 is a randomized, partially blinded (where neither the subjects nor the appropriate clinical center staff are told which treatment or intervention participants are receiving), placebo-controlled cohort designed to further test the safety and efficacy of BMX-010 ointment vs. placebo. Up to approximately 216 adult subjects with AD will be enrolled. At the baseline visit, subjects will be randomized to receive BMX-010 (0.5% or 0.1%) or placebo in a 1:1:1 ratio, by a permuted block randomization schema. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05491447
Study type	Interventional
Source	BioMimetix JV, LLC
Contact
Status	Terminated
Phase	Phase 2
Start date	January 8, 2023
Completion date	April 15, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05018806` - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis	Phase 2
Terminated	`NCT03847389` - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis	Phase 1/Phase 2
Completed	`NCT04090229` - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis	Phase 1
Active, not recruiting	`NCT05388760` - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)	Phase 2
Completed	`NCT05530707` - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer	N/A
Completed	`NCT02595073` - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis	Phase 3
Recruiting	`NCT05509023` - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)	Phase 2
Recruiting	`NCT05048056` - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis	Phase 2
Completed	`NCT04598269` - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis	Phase 2
Recruiting	`NCT03936335` - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn	`NCT03089476` - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy	N/A
Recruiting	`NCT05029895` - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated	`NCT03654755` - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis	Phase 2
Completed	`NCT04556461` - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function	Phase 2
Recruiting	`NCT04818138` - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort	N/A
Completed	`NCT03719742` - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer	N/A
Completed	`NCT05375955` - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.	Phase 2
Completed	`NCT03441568` - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control	N/A
Recruiting	`NCT06366932` - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models	Phase 4
Completed	`NCT03304470` - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis	Phase 2