Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KY1005, SAR445229, A human anti-OX40 ligand monoclonal antibody
Amlitelimab · 13 trials · 7 indications
Clinical response is defined as having vIGA-AD 0 or 1. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^. The validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The Eczema Area and Severity Index (EASI) is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline".
Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75\^ OR vIGA-AD 0 or 1 and EASI-75\^. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline".
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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.
Change in Vh:Cd ratio.
Positive tetanus response is defined as ≥2.5 IU/mL in anti-tetanus immunoglobulin G \[IgG\] titer for participants with a pre-vaccination baseline \[Week 12\] tetanus antibody titer of \>1 IU/mL or a titer ≥ 3-fold increase for participants with a pre-vaccination titer of ≤1IU/mL).
Percentage of participants who experienced TEAEs from baseline during the study
Percentage of participants who experienced TESAEs from baseline during the study
Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of oral corticosteroids (OCS) for the treatment of asthma, a doubling of the dose for 3 or more days, or hospitalization or emergency room visit because of asthma requiring systemic corticosteroids. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.
Maximum serum concentration observed.
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Area under the serum concentration versus time curve extrapolated to infinity.
AUC = area under the serum/plasma concentration curve; AUClast = area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast.
| Arm | Type | Description |
|---|---|---|
| Amlitelimab dose 1 | EXPERIMENTAL | Subcutaneous injection as per protocol |
| Amlitelimab dose 2 | EXPERIMENTAL | Subcutaneous injection as per protocol |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous injection as per protocol |
| 250mg (500mg Loading Dose) KY1005 | EXPERIMENTAL | Every 4 weeks |
| 250mg (No Loading Dose) KY1005 | EXPERIMENTAL | Every 4 weeks |
| 125mg KY1005 | EXPERIMENTAL | Every 4 weeks |
| 62.5mg KY1005 | EXPERIMENTAL | Every 4 weeks |
| Amlitelimab dose 1 + Gluten-free product (GFP) | EXPERIMENTAL | Amlitelimab SC as per protocol + GFP |
| Amlitelimab dose 2 + GFP | EXPERIMENTAL | Amlitelimab SC as per protocol + GFP |
| Amlitelimab dose 3 + GFP | EXPERIMENTAL | Amlitelimab SC as per protocol + GFP |
| Amlitelimab dose 1 + SIGE | EXPERIMENTAL | Amlitelimab SC as per protocol + SIGE |
| Placebo + GFP | PLACEBO_COMPARATOR | Placebo SC as per protocol + GFP |
| Placebo + SIGE | PLACEBO_COMPARATOR | Placebo SC as per protocol + SIGE |
| Amlitelimab | EXPERIMENTAL | Participants will receive amlitelimab and vaccines as per protocol. |
| Amlitelimab dose level 1 | EXPERIMENTAL | Subcutaneous injection as per protocol |
| Amlitelimab dose level 2 | EXPERIMENTAL | Subcutaneous injection as per protocol |
| Amlitelimab 62.5 mg With 125 mg Loading Dose | EXPERIMENTAL | Participants received amlitelimab SC injection at an initial loading dose of 125 mg on Day 1 followed by amlitelimab 62.5 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48. |
| Amlitelimab 125 mg With 250 mg Loading Dose | EXPERIMENTAL | Participants received amlitelimab SC injection at an initial loading dose of 250 mg on Day 1 followed by amlitelimab 125 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48. |
| Amlitelimab 250 mg With 500 mg Loading Dose | EXPERIMENTAL | Participants received amlitelimab SC injection at an initial loading dose of 500 mg on Day 1 followed by amlitelimab 250 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48. |
| Group 1 | ACTIVE_COMPARATOR | Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). |
| Group 2 | EXPERIMENTAL | Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP). |
| Group 3 | ACTIVE_COMPARATOR | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS. |
| Group 4 | EXPERIMENTAL | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP. |
| Amlitelimab and CYP substrates | EXPERIMENTAL | A single oral dose of a CYP450 substrates cocktail which will include caffeine, metoprolol, midazolam, omeprazole, and warfarin will be administered. A single dose of amlitelimab will then be administered on several days. A single oral dose of CYP450 substrates cocktail in combination with the last single dose of amlitelimab. |
| Name | Type | Description |
|---|---|---|
| Amlitelimab | DRUG | Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection |
| Placebo | DRUG | Pharmaceutical form: Injection solution Route of administration: SC injection |
| Topical corticosteroids | DRUG | Pharmaceutical form: Various Topical formulation Route of administration: Topical |
| Topical tacrolimus or pimecrolimus | DRUG | Pharmaceutical form: Various Topical formulation Route of administration: Topical |
| Topical calcineurin inhibitors | DRUG | Pharmaceutical form: Topical formulation Route of administration: Topical |
| SIGE | DIETARY_SUPPLEMENT | Pharmaceutical form: Capsule Route of administration: Oral |
| Gluten-free product (GFP) | DIETARY_SUPPLEMENT | Pharmaceutical form: Capsule Route of administration: Oral |
| Tdap vaccine | BIOLOGICAL | Intramuscular (IM) injection into the deltoid muscle of the upper arm |
| PPS vaccine | BIOLOGICAL | Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm |
| Oral corticosteroids | DRUG | Pharmaceutical form: Oral Route of administration: Oral |
| SAR445229 | COMBINATION_PRODUCT | Single dose |
| Midazolam | DRUG | Pharmaceutical form: Solution Route of administration: Oral |
| Caffeine | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Metoprolol | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Omeprazole | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
| Warfarin | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
Inclusion Criteria: * Participants must be at least 12 years of age inclusive, at the time the informed consent is signed. * Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required ...
Amlitelimab is an investigational monoclonal antibody being developed for inflammatory and immune-mediated conditions, including moderate-to-severe atopic dermatitis, asthma, coeliac disease, and eczema. It is not yet approved for any indication and remains in clinical development.
Amlitelimab targets TNFSF4, also known as OX40 ligand. It is an inhibitor of this target. By binding TNFSF4, amlitelimab is designed to modulate immune cell activation and the inflammatory response associated with atopic dermatitis and other immune-mediated diseases.
Amlitelimab is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the drug across atopic dermatitis, coeliac disease, and related conditions.
Amlitelimab is in Phase 2 and Phase 3 clinical development. It is investigational and has not been approved by the FDA or any regulatory authority. The program includes nine trials in total, with four currently active and five completed.
Amlitelimab is being studied in several trials, including NCT06686628, a completed Phase 1 drug-drug interaction study; NCT06557772, a Phase 2a/b trial in nonresponsive coeliac disease; NCT06407934, a Phase 3 trial in moderate-to-severe atopic dermatitis; and NCT06241118, a Phase 3 trial in atopic dermatitis patients with inadequate response to prior biologics or JAK inhibitors.
Amlitelimab is also known by its development code name, which is not provided here. It should not be confused with other monoclonal antibodies targeting different pathways. Amlitelimab specifically targets TNFSF4 and is developed by Sanofi.