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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06224192 | A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis | PHASE3 | COMPLETED | 151 | — | — | Apr 2, 2024 | Mar 16, 2026 | Mar 25, 2026 | 47 | United States, Canada +2 |
| NCT05899816 | A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER) | PHASE3 | COMPLETED | 221 | — | — | Jun 7, 2023 | Nov 14, 2024 | Nov 5, 2025 | 85 | United States, Canada |
| NCT05882877 | A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) | PHASE3 | ACTIVE NOT_RECRUITING | 2,621 | — | — | May 31, 2023 | Jun 22, 2026 | May 4, 2026 | 547 | United States, Argentina +40 |
| NCT05704738 | A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) | PHASE3 | COMPLETED | 532 | — | — | Apr 20, 2023 | Nov 25, 2025 | Jan 16, 2026 | 246 | United States, Belgium +20 |
| NCT05724199 | A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) | PHASE3 | COMPLETED | 746 | — | — | Feb 21, 2023 | Dec 4, 2024 | Nov 24, 2025 | 234 | United States, Argentina +24 |
| NCT05633355 | A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) | PHASE3 | COMPLETED | 187 | — | — | Jan 30, 2023 | Jul 31, 2025 | Dec 11, 2025 | 77 | United States, Argentina +7 |
| NCT05651711 | A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) | PHASE3 | COMPLETED | 726 | — | — | Dec 14, 2022 | Aug 27, 2024 | Apr 3, 2025 | 197 | United States, Australia +19 |
| NCT05398445 | A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) | PHASE3 | COMPLETED | 769 | — | — | May 31, 2022 | Jan 13, 2025 | Nov 24, 2025 | 202 | United States, Argentina +19 |
| NCT06438263 | A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants | PHASE1 | COMPLETED | 231 | — | — | Aug 6, 2024 | Jul 2, 2025 | Jan 20, 2026 | 3 | United States |
| NCT06268860 | A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants | PHASE1 | COMPLETED | 240 | — | — | Feb 15, 2024 | Oct 8, 2024 | Dec 23, 2025 | 4 | United States, United Kingdom |
| NCT06214481 | A Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese Participants | PHASE1 | COMPLETED | 20 | — | — | Jan 23, 2024 | Jun 5, 2024 | Jan 7, 2026 | 1 | China |
| NCT05891119 | Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis | EARLY_PHASE1 | COMPLETED | 21 | — | — | Jun 3, 2023 | Feb 12, 2025 | Dec 23, 2025 | 7 | United States |
| Arm | Type | Description |
|---|---|---|
| Rocatinlimab Dose 1 Prefilled Syringe (PFS) | EXPERIMENTAL | Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. |
| Rocatinlimab Dose 2 PFS | EXPERIMENTAL | Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. |
| Rocatinlimab Dose 2 Autoinjector (AI) | EXPERIMENTAL | Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks. |
| Rocatinlimab | EXPERIMENTAL | Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. |
| Placebo | PLACEBO_COMPARATOR | Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. |
| ARM A: Dose 1 to Dose 1 | EXPERIMENTAL | Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W. |
| ARM B: Dose 2 to Dose 2 | EXPERIMENTAL | Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W. |
| ARM C: Dose 1 or Dose 2 to Placebo | PLACEBO_COMPARATOR | Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W. |
| ARM D: Placebo to Placebo | PLACEBO_COMPARATOR | Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W. |
| ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 | EXPERIMENTAL | Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab study ROCKET-Orbit will continue to receive OL Rocatinlimab Dose 1 Q4W. |
| ARM F Group | NO_INTERVENTION | Participants in Arm E (OL Rocatinlimab Dose 1 Q4W) who meet defined criteria will have Rocatinlimab withdrawn, but will continue all subsequent study visits. |
| ARM G Group | EXPERIMENTAL | Participants from Arm F who meet defined criteria will resume OL Rocatinlimab Dose 1 Q4W. |
| Arm A: Dose 1 | EXPERIMENTAL | Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort). |
| Arm B: Dose 2 | EXPERIMENTAL | Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort). |
| Arm C: Placebo | EXPERIMENTAL | Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). |
| Arm D: Open-Label Dose 1 | EXPERIMENTAL | Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24. |
| Rocatinlimab Dose 1 + TCS/TCI | EXPERIMENTAL | Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2. |
| Rocatinlimab Dose 2 + TCS/TCI | EXPERIMENTAL | Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. |
| Placebo + TCS/TCI | PLACEBO_COMPARATOR | Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. |
| Arm A | EXPERIMENTAL | Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2 |
| Arm B | EXPERIMENTAL | Rocatinlimab Dose 2 Q4W + loading dose at Week 2 |
| Arm C | PLACEBO_COMPARATOR | Placebo Q4W+ loading dose at Week 2 |
| Treatment A | EXPERIMENTAL | Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection. |
| Treatment B | EXPERIMENTAL | Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection. |
| Rocatinlimab Vial | EXPERIMENTAL | Participants will receive rocatinlimab vial solution SC |
| Rocatinlimab Prefilled Syringe | EXPERIMENTAL | Participants will receive rocatinlimab prefilled syringe solution SC |
| Rocatinlimab and CYP450 Substrates | EXPERIMENTAL | A single oral dose of a CYP450 substrates cocktail which will include caffeine, metoprolol, midazolam, warfarin (with vitamin K), and omeprazole will be administered on Day 1. A single dose of rocatinlimab will then be administered on Days 8, 22, 36, 64, and 92. A single oral dose of CYP450 substrates cocktail in combination with a single dose of rocatinlimab will then be administered on Day 120. |
| Name | Type | Description |
|---|---|---|
| Rocatinlimab Prefilled Syringe | COMBINATION_PRODUCT | Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab. |
| Rocatinlimab AI | COMBINATION_PRODUCT | AI for SC injection self-administration of rocatinlimab. |
| Rocatinlimab | DRUG | Subcutaneous (SC) injection |
| Placebo | DRUG | SC injection |
| Rocatinlimab vial injection | DRUG | Vial solution for SC injection administered on Day 1 |
| Caffeine | DIETARY_SUPPLEMENT | Oral liquid |
| Metoprolol | DRUG | Oral tablet |
| Midazolam | DRUG | Oral liquid |
| Warfarin | DRUG | Oral tablet |
| Vitamin K | DIETARY_SUPPLEMENT | Oral tablet |
| Omeprazole | DRUG | Oral capsule |
Inclusion Criteria: * Age ≥ 12 at Day 1. * Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months. * History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topica...