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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

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10% or more of my skin is affected by atopic dermatitis.

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I have been diagnosed with atopic dermatitis for over a year.

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My average pain score is 4 or more.

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I am at least 18 years old.

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I weigh at least 40 kg.

COAST 1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 40

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

Abdominal Pain

Tremor

Pyrexia

Vomiting

Fatigue

Pneumonia

Arthralgia

Headache

Nausea

Hyperkalaemia

Pain in Extremity

Polycythaemia

BK Virus Infection

Hyperglycaemia

Neutropenia

Osteopenia

Insomnia

Weight Increased

Oropharyngeal Pain

Muscle Spasms

Hypomagnesaemia

Gastrooesophageal Reflux Disease

Acne

Rash

Dizziness

Back Pain

Hypokalaemia

Hypercholesterolaemia

Proteinuria

Oedema

Dyspnoea

Basal Cell Carcinoma

Chest Pain

Hypoglycaemia

Skin Ulcer

Pyelonephritis

Asthenia

Osteonecrosis

Pelvic Pain

Squamous Cell Carcinoma

Osteoporosis

Cervical Vertebral Fracture

Bowen's Disease

Staphylococcal Infection

Escherichia Bacteraemia

Catheter Related Infection

Knee Arthroplasty

Staphylococcal Abscess

Squamous Cell Carcinoma of Skin

Renal Cell Carcinoma

Groin Abscess

Gastroenteritis Viral

Atrial Fibrillation

Dehydration

Incisional Hernia

Spinal Fracture

Post Procedural Haematuria

Uterine Leiomyoma

Hyponatraemia

Hypoaesthesia

Inguinal Hernia

Drug Hypersensitivity

Cholecystitis Acute

Cholecystitis

Pulmonary Embolism

Haematuria

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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,560 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,418 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this clinical investigation open at the present?

"According to clinicaltrials.gov, this medical research endeavour is actively sourcing volunteers. It was initially established on November 29th 2023 and the details have been updated as recently as November 8th of that year."

Answered by AI

What is the census of patients enrolled in this experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial, originally listed on November 29th 2023, is actively seeking volunteers. Approximately 420 individuals need to be recruited from 1 medical centre for participation in the study."

Answered by AI

What is the potential risk associated with Amlitelimab dose 1?

"With the backing of prior clinical data, Amlitelimab dose 1 has been rated a 3 on our team's safety scale. This is due to this being a Phase 3 trial with some evidence of efficacy and multiple rounds demonstrating its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

2023. "A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06130566.

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