Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06407934 | A 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 | PHASE3 | ACTIVE NOT_RECRUITING | 1,541 | — | — | May 8, 2024 | Mar 17, 2027 | Apr 20, 2026 | 326 | United States, Argentina +25 |
| NCT06241118 | A 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 | PHASE3 | RECRUITING | 636 | — | — | Feb 29, 2024 | Sep 29, 2028 | Jun 5, 2026 | 149 | United States, Argentina +21 |
| NCT06224348 | A 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 | PHASE3 | COMPLETED | 643 | — | — | Jan 18, 2024 | Nov 1, 2025 | Dec 2, 2025 | 167 | United States, Argentina +12 |
| NCT06181435 | 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 (COAST 2) | PHASE3 | COMPLETED | 589 | — | — | Dec 21, 2023 | Mar 12, 2026 | Mar 19, 2026 | 142 | United States, Argentina +14 |
| NCT06130566 | 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 | PHASE3 | COMPLETED | 601 | — | — | Nov 8, 2023 | Nov 13, 2025 | Nov 24, 2025 | 148 | United States, Argentina +13 |
| NCT06015308 | A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo | PHASE2 | COMPLETED | 224 | — | — | Oct 6, 2023 | Jan 16, 2026 | Apr 13, 2026 | 57 | United States, Canada |
| NCT05769777 | Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis | PHASE2 | ACTIVE NOT_RECRUITING | 999 | — | — | Apr 3, 2023 | Jun 11, 2031 | Apr 23, 2026 | 174 | United States, Argentina +23 |
| NCT05492578 | Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials | PHASE2 | ENROLLING BY_INVITATION | 1,663 | — | — | Aug 22, 2022 | Jan 22, 2029 | Jun 3, 2026 | 388 | United States, Argentina +27 |
| NCT06686628 | An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates | PHASE1 | COMPLETED | 23 | — | — | Nov 20, 2024 | Apr 2, 2026 | Apr 23, 2026 | 1 | Germany |
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).
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 ≤1 IU/mL).
Percentage of participants who experienced TEAEs from baseline during the study
Percentage of participants who experienced TESAEs from baseline during the study
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 |
| 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 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 |
| 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 |
| 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 ...