← Back to Search

Monoclonal Antibodies

Subcutaneous Amlitelimab for Atopic Dermatitis/Eczema (COAST 1 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
AD involvement of 10% or more of BSA at baseline
Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 40
Awards & highlights

COAST 1 Trial Summary

This trial is testing a drug to treat moderate-to-severe atopic dermatitis. It has a 2-4 week screening period, 24-week randomized, double-blind period and up to 10 visits.

Who is the study for?
Adults over 18 with moderate-to-severe atopic dermatitis (AD) covering at least 10% of their body, who haven't responded well to topical treatments or for whom those aren't advised. Participants should have had AD for a year, weigh over 40 kg, and meet specific severity scores on medical scales.Check my eligibility
What is being tested?
The trial is testing Amlitelimab injections against a placebo in people with AD. It's double-blind, meaning neither the researchers nor participants know who gets the real treatment. The study lasts up to 44 weeks with an option to join a follow-up study.See study design
What are the potential side effects?
Possible side effects of Amlitelimab are not detailed here but may include reactions similar to other medications affecting the immune system such as injection site reactions, infections due to lowered immunity, and potential allergic responses.

COAST 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
10% or more of my skin is affected by atopic dermatitis.
Select...
I have been diagnosed with atopic dermatitis for over a year.
Select...
My average pain score is 4 or more.
Select...
I am at least 18 years old.
Select...
I weigh at least 40 kg.

COAST 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 40 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
+31 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
9%
Abdominal Pain
9%
Tremor
8%
Pyrexia
8%
Vomiting
8%
Fatigue
8%
Pneumonia
7%
Arthralgia
7%
Headache
7%
Nausea
6%
Hyperkalaemia
6%
Pain in Extremity
6%
Polycythaemia
6%
BK Virus Infection
6%
Hyperglycaemia
5%
Osteopenia
5%
Neutropenia
5%
Insomnia
5%
Weight Increased
5%
Oropharyngeal Pain
5%
Muscle Spasms
5%
Hypomagnesaemia
5%
Gastrooesophageal Reflux Disease
5%
Acne
5%
Rash
5%
Dizziness
4%
Back Pain
4%
Hypokalaemia
4%
Hypercholesterolaemia
4%
Proteinuria
3%
Oedema
3%
Dyspnoea
2%
Basal Cell Carcinoma
2%
Chest Pain
2%
Hypoglycaemia
2%
Skin Ulcer
2%
Pyelonephritis
1%
Catheter Related Infection
1%
Staphylococcal Abscess
1%
Groin Abscess
1%
Knee Arthroplasty
1%
Renal Cell Carcinoma
1%
Asthenia
1%
Osteonecrosis
1%
Osteoporosis
1%
Staphylococcal Infection
1%
Escherichia Bacteraemia
1%
Cervical Vertebral Fracture
1%
Squamous Cell Carcinoma
1%
Pelvic Pain
1%
Squamous Cell Carcinoma of Skin
1%
Bowen's Disease
1%
Gastroenteritis Viral
1%
Atrial Fibrillation
1%
Dehydration
1%
Incisional Hernia
1%
Spinal Fracture
1%
Post Procedural Haematuria
1%
Uterine Leiomyoma
1%
Hyponatraemia
1%
Hypoaesthesia
1%
Inguinal Hernia
1%
Drug Hypersensitivity
1%
Cholecystitis Acute
1%
Cholecystitis
1%
Pulmonary Embolism
1%
Haematuria
1%
Brain Stem Infarction
1%
Lung Adenocarcinoma
1%
Coccidioidomycosis
1%
Viral Infection
1%
Appendicitis
1%
Bacteraemia
1%
Lung Cancer Metastatic
1%
Normal Newborn
1%
Cellulitis
1%
Urosepsis
1%
Gastroenteritis
1%
Osteomyelitis
1%
Sepsis
1%
Chest Discomfort
1%
Hyperthermia
1%
Malignant Melanoma
1%
Anal Cancer
1%
Pancreatitis
1%
Retroperitoneal Haematoma
1%
Renal Failure Acute
1%
Nephrolithiasis
1%
Urinary Tract Obstruction
1%
Deep Vein Thrombosis
1%
Hypertensive Emergency
1%
Peripheral Ischaemia
1%
Thrombophlebitis
1%
Cardiac Arrest
1%
Pericarditis
1%
Blood Glucose Increased
1%
Hungry Bone Syndrome
1%
Muscular Weakness
1%
Cerebrovascular Accident
1%
Intracranial Aneurysm
1%
Obstructive Airways Disorder
1%
Pleurisy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Mycophenolate Mofetil + Sirolimus

COAST 1 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

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.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,172 Previous Clinical Trials
3,516,405 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
866 Previous Clinical Trials
2,019,734 Total Patients Enrolled
~280 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top