What is the mechanism of action of this treatment?

Common treatments for Atopic Dermatitis (AD) include monoclonal antibodies and other systemic therapies that target specific components of the immune system. Monoclonal antibodies like Dupilumab inhibit cytokines such as IL-4 and IL-13, which play key roles in the inflammatory process of AD, thereby reducing inflammation and itching. Amlitelimab, a monoclonal antibody targeting OX40L, modulates T-cell activation and survival, offering another pathway to control the immune response. These targeted therapies are particularly important for patients with moderate to severe AD who do not respond to topical treatments, as they provide more effective symptom management and improve overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly monoclonal antibodies like dupilumab and tralokinumab, often have side effects such as injection site reactions, conjunctivitis, and upper respiratory tract infections. Systemic treatments like apremilast can cause gastrointestinal issues, headaches, and weight loss, while cyclosporine may lead to hypertension and renal dysfunction. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, particularly focusing on monoclonal antibodies and systemic therapies. Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha, has been a significant advancement, showing efficacy in reducing symptoms of moderate-to-severe AD. Other systemic treatments include cyclosporine, methotrexate, and azathioprine, which have been used for their immunosuppressive effects. More recently, JAK inhibitors like abrocitinib and upadacitinib have also been approved, offering new options for patients with moderate-to-severe AD. These treatments, similar to Amlitelimab, aim to modulate the immune response to alleviate the symptoms of AD.

What other types of research exist?

Promising novel alternatives to Amlitelimab for Atopic Dermatitis patients include Dupilumab, a monoclonal antibody targeting IL-4Rα, and Upadacitinib, a JAK inhibitor. Both have shown significant efficacy and safety in treating moderate to severe AD in recent clinical trials.

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Monoclonal Antibodies

Amlitelimab for Atopic Dermatitis (COAST 1) (COAST 1 Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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?

Must not have

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)?

Timeline

Screening 2 weeks

Treatment 24 weeks

Follow Up 16 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

The most frequently reported side effects in participants who received amlitelimab (reported in ≥ 5% of study participants) and more frequent compared to those who received placebo (a ≥1% difference between amlitelimab compared to placebo) were: nasopharyngitis, COVID-19, and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 2 weeks1 visit

Treatment ~ 24 weeks8 visits

Follow Up ~ 16 weeks1 visit

Screening ~ 2 weeks

Treatment ~ 24 weeks

Follow Up ~16 weeks

This trial's timeline: 2 weeks for screening, 24 weeks for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24

EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

Secondary study objectives

Absolute change in SCORAD index from baseline

Absolute change in weekly average of daily PP-NRS from baseline

Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline

+29 more

Side effects data

From 2009 Phase 4 trial • 305 Patients • NCT00121810

33%

Diarrhoea

22%

Urinary Tract Infection

20%

Blood Creatinine Increased

19%

Leukopenia

16%

Hypertension

13%

Oedema Peripheral

13%

Hyperlipidaemia

12%

Upper Respiratory Tract Infection

11%

Anaemia

10%

Cough

10%

Nasopharyngitis

Abdominal Pain

Tremor

Vomiting

Pyrexia

Fatigue

Pneumonia

Headache

Arthralgia

Nausea

Pain in Extremity

Hyperkalaemia

Polycythaemia

BK Virus Infection

Hyperglycaemia

Insomnia

Neutropenia

Oropharyngeal Pain

Muscle Spasms

Osteopenia

Weight Increased

Hypomagnesaemia

Gastrooesophageal Reflux Disease

Acne

Rash

Dizziness

Back Pain

Hypokalaemia

Hypercholesterolaemia

Proteinuria

Oedema

Dyspnoea

Hypoglycaemia

Skin Ulcer

Chest Pain

Basal Cell Carcinoma

Pyelonephritis

Spinal Fracture

Atrial Fibrillation

Bowen's Disease

Staphylococcal Abscess

Cholecystitis Acute

Escherichia Bacteraemia

Haematuria

Asthenia

Hyponatraemia

Drug Hypersensitivity

Staphylococcal Infection

Osteonecrosis

Groin Abscess

Pelvic Pain

Post Procedural Haematuria

Renal Cell Carcinoma

Catheter Related Infection

Gastroenteritis Viral

Osteoporosis

Hypoaesthesia

Cervical Vertebral Fracture

Cholecystitis

Pulmonary Embolism

Inguinal Hernia

Uterine Leiomyoma

Squamous Cell Carcinoma of Skin

Dehydration

Squamous Cell Carcinoma

Incisional Hernia

Knee Arthroplasty

Brain Stem Infarction

Lung Adenocarcinoma

Coccidioidomycosis

Viral Infection

Appendicitis

Bacteraemia

Lung Cancer Metastatic

Normal Newborn

Cellulitis

Urosepsis

Gastroenteritis

Osteomyelitis

Sepsis

Chest Discomfort

Hyperthermia

Malignant Melanoma

Anal Cancer

Pancreatitis

Retroperitoneal Haematoma

Renal Failure Acute

Nephrolithiasis

Urinary Tract Obstruction

Deep Vein Thrombosis

Hypertensive Emergency

Peripheral Ischaemia

Thrombophlebitis

Cardiac Arrest

Pericarditis

Blood Glucose Increased

Hungry Bone Syndrome

Muscular Weakness

Cerebrovascular Accident

Intracranial Aneurysm

Obstructive Airways Disorder

Pleurisy

100%

80%

60%

40%

20%

Study treatment Arm

Mycophenolate Mofetil + Cyclosporine or Tacrolimus

Mycophenolate Mofetil + Sirolimus

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atopic Dermatitis (AD) include monoclonal antibodies and other systemic therapies that target specific components of the immune system. Monoclonal antibodies like Dupilumab inhibit cytokines such as IL-4 and IL-13, which play key roles in the inflammatory process of AD, thereby reducing inflammation and itching. Amlitelimab, a monoclonal antibody targeting OX40L, modulates T-cell activation and survival, offering another pathway to control the immune response. These targeted therapies are particularly important for patients with moderate to severe AD who do not respond to topical treatments, as they provide more effective symptom management and improve overall quality of life.