Amlitelimab for Atopic Dermatitis (COAST 1) (COAST 1 Trial)
Palo Alto (17 mi)Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests an injectable treatment called amlitelimab for people aged 12 and older with moderate to severe eczema that doesn't respond well to creams or ointments. The treatment aims to reduce skin inflammation and itching by blocking specific proteins in the immune system. The study will evaluate how effective and safe amlitelimab is.
Is the drug Amlitelimab a promising treatment for atopic dermatitis/eczema?The information provided does not include specific details about Amlitelimab, so we cannot determine if it is a promising treatment for atopic dermatitis/eczema based on this data.567910
What data supports the idea that Subcutaneous Amlitelimab for Atopic Dermatitis/Eczema is an effective treatment?The available research does not provide specific data on the effectiveness of Subcutaneous Amlitelimab for Atopic Dermatitis/Eczema. Instead, it discusses other treatments like abrocitinib, ruxolitinib, and baricitinib, which have shown effectiveness in treating the condition. For example, abrocitinib and upadacitinib were found to be among the most effective systemic therapies in clinical trials, with high percentages of improvement in patients. Without specific data on Amlitelimab, we cannot compare its effectiveness to these treatments.368911
What safety data is available for Amlitelimab in treating atopic dermatitis?The provided research does not contain specific safety data for Amlitelimab (also known as KY-1005, KY1005, KY 1005, SAR-445229, SAR 445229, SAR445229) in the treatment of atopic dermatitis. The studies mentioned focus on other treatments such as dupilumab, abrocitinib, and ruxolitinib, among others. Therefore, no direct safety data for Amlitelimab is available in the given research.123410
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should not have received certain therapies within a specified timeframe before the baseline visit. It's best to discuss your current medications with the trial team to get a clear answer.
Eligibility Criteria
You are eligible if you have been diagnosed with moderate-to-severe AD for a year or longer and used topical corticosteroids or topical calcineurin inhibitors without adequate benefit from topical medications within the last 6 months or used systemic therapies for AD without adequate benefit within the last 12 months.Inclusion Criteria
Have you had atopic dermatitis for at least 1 year?
In the past six months, have you had a poor response to any of the treatments you took for your atopic dermatitis?
Does your atopic dermatitis cover a significant portion of your body?
Exclusion Criteria
Have you been diagnosed with any of the following: psoriasis, tinea corporis, or lupus erythematosus?
In the past year, have you taken any of the following medications: Abrocitinib (brand name Cibinqo), Upadacitinib (brand name Rinvoq), or Baricitinib (brand name Olumiant)?
Have you experienced suicidal ideation or thoughts of self-harm in the past 6 months?
Treatment Details
Atopic dermatitis is an immune system condition. The investigational drug, amlitelimab, is an immunotherapy that targets the inflammation cascade. It is aimed to calm the immune system to prevent inflammation. Amlitelimab has been shown to be well tolerated by patients in previous clinical studies but is not yet approved for treating atopic dermatitis.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Amlitelimab dose 2Experimental Treatment1 Intervention
Subcutaneous injection as per protocol
Group II: Amlitelimab dose 1Experimental Treatment1 Intervention
Subcutaneous injection as per protocol
Group III: PlaceboPlacebo Group1 Intervention
Subcutaneous injection as per protocol
Find a clinic near you
Research locations nearbySelect from list below to view details:
Investigational Site Number : 1241108Niagara Falls, Canada
Metro Boston Clinical Partners- Site Number : 8401128Needham, MA
Revival Research - Doral- Site Number : 8401012Dearborn, MI
Investigational Site Number : 1240013Toronto, Canada
More Trial Locations
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Who is running the clinical trial?
SanofiLead Sponsor
References
The efficacy, tolerability and safety of a new oral formulation of Sandimmun--Sandimmun Neoral in severe refractory atopic dermatitis. [2013]To investigate the efficacy, tolerability and safety of a new oral formulation of Sandimmun-Sandimmun Neoral in severe refractory atopic dermatitis in an open, multicenter study.
TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. [2021]A long-term prospective observational safety study is essential to characterize fully the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset.
Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. [2021]Given the lack of head-to-head studies of systemic therapies in moderate-to-severe atopic dermatitis (AD), network meta-analyses (NMAs) can provide comparative efficacy and safety data to inform clinical decision-making. In this NMA, eligible randomized controlled trials (RCTs) published before 24 October 2019 were identified by a systematic literature review. Short-term (12-16 weeks) efficacy (Investigator's Global Assessment [IGA] and Eczema Area and Severity Index [EASI] responses), patient-reported outcomes (PROs) and safety data from each trial were abstracted and analysed separately for monotherapy and combination therapy (systemic plus topical anti-inflammatory therapy). RCTs were analysed in fixed-effects and random-effects Bayesian NMA models. Overall, 19 phase 2 and phase 3 RCTs of abrocitinib, baricitinib, dupilumab, lebrikizumab, nemolizumab, tralokinumab and upadacitinib were included. In monotherapy RCTs, upadacitinib 30 mg once daily (QD) had the numerically highest efficacy (83.6% achieved ≥50% improvement in EASI [EASI-50 response]), followed by abrocitinib 200 mg QD (74.6%), upadacitinib 15 mg QD (70.5%), dupilumab 300 mg every 2 weeks (Q2W) (63.4%) and abrocitinib 100 mg QD (56.7%). Similar trends in EASI-75 and EASI-90 response were observed. In combination therapy RCTs, abrocitinib 200 mg QD had the highest EASI-50 (86.6%), followed by dupilumab 300 mg Q2W (82.4%) and abrocitinib 100 mg QD (79.7%). Similar findings were observed for IGA response and PROs. In monotherapy and combination therapy RCTs, the probability of treatment-emergent adverse events (TEAEs) was higher among all active treatments than with placebo (except for dupilumab 300 mg Q2W [odds ratio (OR), 0.96; 95% credible interval (CrI), 0.45-2.18] and abrocitinib 100 mg QD [OR, 0.95; 95% CrI, 0.35-2.66] in combination therapy RCTs), although active treatments did not significantly differ from one another. Abrocitinib, dupilumab and upadacitinib were consistently the most effective systemic therapies in adult and adolescent patients with AD, with no significant TEAE differences in short-term RCTs.
Atopic dermatitis in adolescents: Effectiveness and safety of dupilumab in a 16-week real-life experience during the COVID-19 pandemic in Italy. [2021]Dupilumab showed significant improvement of adolescent atopic dermatitis (AD) signs and symptoms in clinical trials, with a good safety profile. Herein we report the real-word effectiveness and safety of dupilumab in adolescents with moderate to severe AD from January to October 2020, during the COVID-19 pandemic in Italy. All patients had a diagnosis of AD for a mean [SD] 12.8 [3.1] years. Baseline demographics, AD characteristics (EASI, cDLQI, NRS itch score, NRS sleep loss score) at baseline and week 16, and safety data were collected. Nineteen patients (52.6% men; mean [SD] age, 15.6 [1.4] years [range, 13-17 years]) were included in the analysis. All patients reached EASI-50 and 78.9% EASI-75, especially in those with EASI≥30 and BMI
Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial. [2022]Dupilumab subcutaneous injection is approved for treating moderate-to-severe atopic dermatitis (AD) in adolescents, but there has been too little research on an efficacious systemic oral treatment with a favorable benefit-risk profile for adolescents with moderate-to-severe AD.
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. [2022]Pivotal phase III studies demonstrated that abrocitinib, an oral, once-daily, JAK1-selective inhibitor, is effective treatment for moderate-to-severe atopic dermatitis (AD) as monotherapy and in combination with topical therapy.
Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. [2022]A significant improvement in clinical signs was demonstrated with abrocitinib relative to placebo in adolescents with moderate-to-severe atopic dermatitis (AD) in three phase 3, randomized, double-blinded, placebo-controlled studies (JADE TEEN [ClinicalTrials.gov, NCT03796676], JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]).
Clinical Tailoring of Baricitinib 2 mg in Atopic Dermatitis: Baseline Body Surface Area and Rapid Onset of Action Identifies Response at Week 16. [2022]Baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, is indicated in the European Union and Japan for treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. In the ongoing, placebo-controlled, phase 3 trial BREEZE-AD5, once-daily oral baricitinib 2-mg monotherapy improved disease in moderate-to-severe AD patients who had an inadequate response or intolerance to topical corticosteroids. This post-hoc analysis aimed to identify responders to baricitinib 2 mg, using a proposed clinical tailoring approach based on baseline body surface area (BSA) affected and early clinical improvement, in BREEZE-AD5.
Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib. [2022]Atopic dermatitis (AD) is a common chronic, pruritic inflammatory skin disease that profoundly impacts patients' quality of life. As the first FDA-approved topical JAK inhibitor, ruxolitinib 1.5% cream represents a novel therapeutic topical agent for the treatment of AD. The objective of this review is to summarize the efficacy and safety of ruxolitinib cream in patients with AD based on the available evidence. Overall, ruxolitinib cream demonstrated high efficacy and a favorable safety profile for treating atopic dermatitis.
Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. [2023]Ruxolitinib cream demonstrated safety and efficacy over 8 weeks in 2 double-blind phase 3 atopic dermatitis studies (NCT03745638/NCT03745651).
Use of tofacitinib in baricitinib-refractory atopic dermatitis: An example of JAK inhibitor switching. [2023]Atopic dermatitis (AD) is predominantly mediated by a T-helper 2 immune system response. While JAK inhibitors have gained treatment approval for AD, data regarding interclass efficacy and therapeutic rationale is lacking. We report a patient with recalcitrant AD who failed baricitinib but demonstrated an excellent response to the pan-JAK inhibitor tofacitinib.