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amlitelimab

TypeInjection StageStopped · Phase 3 Why it stoppedNot better than existing options · Sanofi · Jul 24, 2026“Sanofi today announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis (AD).” (Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews) Latest updateJun 10, 2026Phase 3 main data collected

What stands out

New approach in eczema

  • Injection every 4 weeks in trials
  • Binds to OX40L, the signal that flips the OX40 switch on T cells
Derived from FDA substance registry · NCT05131477 · UniProt P23510 ·
11 US eczema labels (Cibinqo, Eucrisa, Adquey, Dupixent, Ebglyss, Nemluvio, Zoryve, Opzelura, Vtama, Adbry, Rinvoq)
· This is a summary of public records for informational purposes only. It is not medical advice.

Results

Trial: STREAM-AD
Clear or almost clear skinAfter 16 weeks
Placebo79 people
5 in 100
250 mg (500 mg loading dose) KY100577 people
22 in 100
250 mg (no loading dose) KY100578 people
14 in 100
125 mg KY100577 people
20 in 100
62.5 mg KY100579 people
25 in 100
02040
+17
more people in 100 reached it on 250 mg (500 mg loading dose) KY1005 than on placebo.
The sponsor’s 95% confidence range is 6 to 27 more (out of 100).
+9
more people in 100 reached it on 250 mg (no loading dose) KY1005 than on placebo.
The sponsor’s 95% confidence range is 0 to 18 more (out of 100).
+14
more people in 100 reached it on 125 mg KY1005 than on placebo.
The sponsor’s 95% confidence range is 4 to 24 more (out of 100).
+20
more people in 100 reached it on 62.5 mg KY1005 than on placebo.
The sponsor’s 95% confidence range is 10 to 31 more (out of 100).
Eczema score (EASI) at least 75% betterAfter 16 weeks
Placebo79 people
11 in 100
250 mg (500 mg loading dose) KY100577 people
40 in 100
250 mg (no loading dose) KY100578 people
39 in 100
125 mg KY100577 people
43 in 100
62.5 mg KY100579 people
41 in 100
03060
+29
more people in 100 reached it on 250 mg (500 mg loading dose) KY1005 than on placebo.
The sponsor’s 95% confidence range is 16 to 42 more (out of 100).
+27
more people in 100 reached it on 250 mg (no loading dose) KY1005 than on placebo.
The sponsor’s 95% confidence range is 14 to 40 more (out of 100).
+29
more people in 100 reached it on 62.5 mg KY1005 than on placebo.
The sponsor’s 95% confidence range is 16 to 42 more (out of 100).
Eczema score (EASI) at least 90% betterAfter 16 weeks
Placebo79 people
4 in 100
250 mg (500 mg loading dose) KY100577 people
16 in 100
250 mg (no loading dose) KY100578 people
14 in 100
125 mg KY100577 people
17 in 100
62.5 mg KY100579 people
19 in 100
01020
Eczema score (EASI) 100% betterAfter 16 weeks
Placebo79 people
1 in 100
250 mg (500 mg loading dose) KY100577 people
4 in 100
250 mg (no loading dose) KY100578 people
1 in 100
125 mg KY100577 people
3 in 100
62.5 mg KY100579 people
1 in 100
01020
NCT05131477 · Ages 18–75 · Results posted Jul 2025 · This is a summary of trial data for informational purposes only. It is not medical advice.
Trial: STREAM-AD
Itch score at least 4 points betterAfter 16 weeks
Placebo79 people
5 in 100
250 mg (500 mg loading dose) KY100577 people
25 in 100
250 mg (no loading dose) KY100578 people
19 in 100
125 mg KY100577 people
21 in 100
62.5 mg KY100579 people
23 in 100
02040
+19
more people in 100 reached it on 250 mg (500 mg loading dose) KY1005 than on placebo.
The sponsor’s 95% confidence range is 9 to 30 more (out of 100).
+14
more people in 100 reached it on 250 mg (no loading dose) KY1005 than on placebo.
The sponsor’s 95% confidence range is 4 to 24 more (out of 100).
+16
more people in 100 reached it on 125 mg KY1005 than on placebo.
The sponsor’s 95% confidence range is 5 to 26 more (out of 100).
+18
more people in 100 reached it on 62.5 mg KY1005 than on placebo.
The sponsor’s 95% confidence range is 7 to 28 more (out of 100).
NCT05131477 · Ages 18–75 · Results posted Jul 2025 · This is a summary of trial data for informational purposes only. It is not medical advice.
What is IGA?
  • IGA stands for Investigator Global Assessment.
  • The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.As this trial registered it · NCT05131477
What is EASI?
  • EASI stands for Eczema Area and Severity Index.
  • Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.As this trial registered it · NCT05131477
What is the itch score?
  • NRS stands for Numerical Rating Scale.
  • The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.As this trial registered it · NCT05131477
Why this trial?

amlitelimab has one trial with posted results, and STREAM-AD compared the drug with placebo on a result this page charts.

History

Earliest recorded event: Dec 13, 2018. This timeline shows events collected by Eczema Radar and may not include the treatment’s full history. Study details reflect the latest registry record available here.

  • Jun 10, 2026Phase 3 main data collectedA Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT06407934
  • Apr 2, 2026Phase 1 trial completedAn Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates ClinicalTrials.gov NCT06686628
  • Mar 12, 2026Phase 3 trial completedA 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 (COAST 2) ClinicalTrials.gov NCT06181435
  • Jan 16, 2026Phase 2 trial completedA Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo ClinicalTrials.gov NCT06015308
  • Nov 25, 2025Phase 3 main data collectedA 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 (COAST 2) ClinicalTrials.gov NCT06181435
  • Nov 21, 2025Phase 1 main data collectedAn Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates ClinicalTrials.gov NCT06686628
  • Nov 13, 2025Phase 3 trial completedA 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 NCT06130566
  • Nov 1, 2025Phase 3 trial completedA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids ClinicalTrials.gov NCT06224348
  • Oct 1, 2025Phase 2 main data collectedA Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo ClinicalTrials.gov NCT06015308
  • Aug 21, 2025Phase 3 main data collectedA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids ClinicalTrials.gov NCT06224348
  • Jul 23, 2025Phase 3 main data collectedA 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 NCT06130566
  • Jul 3, 2025Phase 2 results postedStudy Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study ClinicalTrials.gov NCT05131477
  • Nov 20, 2024Phase 1 trial startedAn Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates ClinicalTrials.gov NCT06686628
  • May 8, 2024Phase 3 trial startedA Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT06407934
  • Feb 29, 2024Phase 3 trial startedA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor ClinicalTrials.gov NCT06241118
  • Feb 21, 2024Phase 2 trial completedStudy Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study ClinicalTrials.gov NCT05131477
  • Jan 18, 2024Phase 3 trial startedA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids ClinicalTrials.gov NCT06224348
  • Dec 21, 2023Phase 3 trial startedA 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 (COAST 2) ClinicalTrials.gov NCT06181435
  • Nov 8, 2023Phase 3 trial startedA 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 NCT06130566
  • Oct 6, 2023Phase 2 trial startedA Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo ClinicalTrials.gov NCT06015308
  • Apr 26, 2023Phase 2 main data collectedStudy Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study ClinicalTrials.gov NCT05131477
  • Apr 3, 2023Phase 2 trial startedOpen Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis ClinicalTrials.gov NCT05769777
  • Aug 22, 2022Phase 2/3 trial startedLong-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials ClinicalTrials.gov NCT05492578
  • Dec 13, 2021Phase 2 trial startedStudy Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study ClinicalTrials.gov NCT05131477
  • Oct 8, 2020Phase 2 trial completedA Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis ClinicalTrials.gov NCT03754309
  • May 12, 2020Phase 2 main data collectedA Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis ClinicalTrials.gov NCT03754309
  • Dec 13, 2018Phase 2 trial startedA Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis ClinicalTrials.gov NCT03754309

Sources

Trials