Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Amlitelimab, KY1005, A human anti-OX40 ligand monoclonal antibody
SAR445229 · 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 ...
SAR445229 is an investigational monoclonal antibody developed by Sanofi. It is a Phase 1 clinical-stage candidate, and its specific disease indications have not been disclosed. The compound targets the OX40L protein and has been studied in a completed Phase 1 trial in healthy adult volunteers.
SAR445229 targets OX40L, a protein that acts as a ligand in immune signaling pathways. By binding OX40L, the monoclonal antibody is designed to interfere with OX40L-mediated interactions. OX40L is the only molecular target identified for this asset, and the antibody modality reflects that protein-targeting approach.
SAR445229 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this monoclonal antibody. The company has advanced the asset into Phase 1 testing, with one completed trial in healthy volunteers conducted in the United States.
SAR445229 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The program has one completed Phase 1 trial, and no active trials are currently listed for this asset.
SAR445229 has been evaluated in one completed Phase 1 trial, NCT07146750, titled a bioequivalence study of amlitelimab delivered by two different devices in healthy adult participants. The trial enrolled 212 healthy volunteers in the United States, was randomized and active-controlled, and included participants aged 18 years and older.
SAR445229 and amlitelimab refer to the same monoclonal antibody asset from Sanofi. The completed Phase 1 bioequivalence study, NCT07146750, was conducted under the amlitelimab name, while SAR445229 is the alternate designation used for this OX40L-targeting candidate.