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Also known as Rocatinlimab vial injection, Rocatinlimab vial, Rocatinlimab Prefilled Syringe, AMG 451, KHK4083
Rocatinlimab · 11 trials · 2 indications
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Participants received 1 dose of a meningococcal vaccine at Week 20. The antibody response to the meningococcal vaccine was assessed by measuring serum anti-meningococcal IgG by an immunoassay.
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention.
| 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 | 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...
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Rocatinlimab is an investigational monoclonal antibody being developed for the treatment of moderate-to-severe atopic dermatitis. It is designed for self-administration in adolescent and adult patients. The drug has been studied in multiple clinical trials, including Phase 3 studies, but is not yet approved for any indication.
Rocatinlimab targets TNFRSF4, also known as OX40. It acts as an antagonist, blocking the OX40 receptor to modulate T-cell activity. This mechanism is intended to reduce inflammation associated with atopic dermatitis. The target class is antagonist, and the drug is a monoclonal antibody.
Rocatinlimab is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is responsible for the clinical development program, which includes multiple Phase 1 and Phase 3 trials in atopic dermatitis and healthy volunteers.
Rocatinlimab is in Phase 3 clinical development. It has completed 11 trials in total, including Phase 1 bioavailability studies and Phase 3 studies in atopic dermatitis. The drug remains investigational and has not been approved by the FDA for any indication.
Rocatinlimab has been evaluated in 11 completed clinical trials, including NCT06438263, a Phase 1 bioavailability study of an autoinjector and vial in healthy participants; NCT06268860, a Phase 1 bioavailability study of vial and prefilled syringe; NCT06224192, a Phase 3 self-administration study in adolescents and adults with atopic dermatitis; and NCT06214481, a Phase 1 study in healthy Chinese participants.
Yes, Rocatinlimab vial injection, Rocatinlimab vial, and Rocatinlimab prefilled syringe are alternative names or presentations of the same drug, Rocatinlimab. These refer to different formulations or delivery devices, such as a vial for injection or a prefilled syringe, but the active substance is identical.