Clinical Trials Logo
  1. Home
  2. Atopic Dermatitis
  3. NCT05932654

POC Study to Evaluate BSI-045B Monotherapy and BSI-045B add-on Therapy With Dupilumab in Atopic Dermatitis — ADAMANT  

Atopic Dermatitis Clinical Trial

Official title:
A Phase 2a, Multicenter, Proof-of-Concept Clinical Trial to Evaluate Efficacy and Safety of BSI-045B mAb Injection as Monotherapy or Add-on Therapy With Dupilumab in Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Summary

The study is a multicenter clinical trial and is designed as a proof-of-concept study to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B following SC injections, as monotherapy or as add-on therapy with dupilumab. The study will enroll patients with moderate to severe AD in 4 cohorts. There will be 2 Monotherapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. There will be 2 Add-on Therapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. Patients in the Monotherapy Cohorts will be treated with BSI 045B. Patients in the Add-on Therapy Cohorts will be treated with BSI-045B, concomitantly with steady-state dupilumab treatment. Patients in each of these 4 cohorts will initially be treated with a loading dose of BSI-045B given every week (QW) for 3 weeks. Thereafter, BSI-045B will be administered every 2 weeks (Q2W) and patients will receive their assigned dose of BSI-045B (300 mg or 480 mg) Q2W through Week 24.

Clinical Trial Description

This study is a Phase 2a, proof-of-concept clinical study designed to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B injection after 12 and 24 weeks of treatment with BSI 045B, without (Monotherapy Cohorts) or with dupilumab (Add-on Therapy Cohorts) in patients with moderate to severe AD. The study will be unblinded. Following a loading dose of BSI-045B (300 mg or 480 mg) SC QW for 3 weeks, patients will move to a dose (300 mg or 480 mg) SC Q2W through Week 24. The total Treatment Period for both the Monotherapy Cohorts and the Add-on Therapy Cohorts will be 24 weeks, followed by a 12-week Follow-up Period. The SC will monitor the study to identify questions concerning safety and eligibility. The primary efficacy endpoint is the proportion of patients with EASI75 at Week 12, compared with baseline. Efficacy assessments will be conducted at Screening, within the first hour prior to dosing on Day 1, at all subsequent visits, and at the time of early withdrawal from the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05932654
Study type Interventional
Source Biosion, Inc.
Contact Hugh M Davis, PhD
Phone +1-484-431-8137
Email Hugh.Davis@Biosion.com
Status Recruiting
Phase Phase 2
Start date July 31, 2023
Completion date November 18, 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