TypeInjectionStageStopped · Phase 3Why it stoppedSafety (a rare cancer) · Amgen/Kyowa Kirin · Mar 3, 2026“Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, today announced the discontinuation of all ongoing clinical trials for rocatinlimab” (Kyowa Kirin Announces Discontinuation of Rocatinlimab Clinical Trials)Latest updateUpdated recently. Aug 28, 2026Phase 3 results posted
What stands out
New approach in eczema
Injection every 4 or 8 weeks in trials
Binds to OX40, a switch on T cells that keeps an immune response going
more people in 100 reached it on Rocatinlimab 150 mg than on placebo.
The sponsor’s 95% confidence range is 2 to 14 more (out of 100).
+14
more people in 100 reached it on Rocatinlimab 300 mg than on placebo.
The sponsor’s 95% confidence range is 8 to 20 more (out of 100).
Eczema score (EASI) at least 75% betterAfter 24 weeks
Placebo219 people
13 in 100
Rocatinlimab 150 mg215 people
36 in 100
Rocatinlimab 300 mg326 people
42 in 100
03060
+23
more people in 100 reached it on Rocatinlimab 150 mg than on placebo.
The sponsor’s 95% confidence range is 15 to 31 more (out of 100).
+30
more people in 100 reached it on Rocatinlimab 300 mg than on placebo.
The sponsor’s 95% confidence range is 22 to 36 more (out of 100).
Eczema score (EASI) at least 90% betterAfter 24 weeks
Placebo219 people
7 in 100
Rocatinlimab 150 mg215 people
25 in 100
Rocatinlimab 300 mg326 people
27 in 100
02040
+17
more people in 100 reached it on Rocatinlimab 150 mg than on placebo.
The sponsor’s 95% confidence range is 10 to 24 more (out of 100).
+20
more people in 100 reached it on Rocatinlimab 300 mg than on placebo.
The sponsor’s 95% confidence range is 14 to 26 more (out of 100).
NCT05398445 · Ages 18+ · Results posted Jul 2026 · This is a summary of trial data for informational purposes only. It is not medical advice.
Trial: ROCKET-Ignite
Itch score at least 4 points betterAfter 16 weeks
Placebo203 people
8 in 100
Rocatinlimab 150 mg205 people
22 in 100
Rocatinlimab 300 mg306 people
24 in 100
02040
+14
more people in 100 reached it on Rocatinlimab 150 mg than on placebo.
The sponsor’s 95% confidence range is 7 to 20 more (out of 100).
+15
more people in 100 reached it on Rocatinlimab 300 mg than on placebo.
The sponsor’s 95% confidence range is 9 to 21 more (out of 100).
NCT05398445 · Ages 18+ · Results posted Jul 2026 · This is a summary of trial data for informational purposes only. It is not medical advice.
What is IGA?
IGA stands for Investigator's Global Assessment.
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'.As this trial registered it · NCT05398445 (the full definition is there)
What is EASI?
EASI stands for Eczema Area and Severity Index.
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.As this trial registered it · NCT05398445 (the full definition is there)
What is the itch score?
NRS stands for Numeric Rating Scale.
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.As this trial registered it · NCT05398445
Why this trial?
Of rocatinlimab’s 7 trials with posted results, ROCKET-Ignite is shown first: of the trials that compared the drug with placebo on a result this page charts, it tested more doses (2). ROCKET-Horizon, a matching trial the sponsor ran alongside it, is in the list below. We rank those trials by whether they set out to measure skin clearing, whether they tested the drug on its own, their phase, whether they were randomised, whether they included adults, whether they ran in the US, how many doses they tested, how many US sites they had, their size, and then how recently they finished. A trial that was an extension or withdrawal study is listed but never shown first.
Earliest recorded event: Oct 22, 2018. This timeline shows events collected by Eczema Radar and may not include the treatment’s full history. Study details reflect the latest registry record available here.
Aug 28, 2026Phase 3 results postedA Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05704738
Aug 6, 2026Phase 3 results postedA Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05724199
Jul 24, 2026Phase 3 results postedA Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05633355
Jul 23, 2026Phase 3 results posted · Basic-science trialA Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)ClinicalTrials.gov NCT05899816
Jul 23, 2026Phase 3 results postedA Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)ClinicalTrials.gov NCT05398445
Jun 26, 2026Phase 3 results postedA Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)ClinicalTrials.gov NCT05651711
Mar 16, 2026Phase 3 trial completedA Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic DermatitisClinicalTrials.gov NCT06224192
Nov 25, 2025Phase 3 trial completedA Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05704738
Jul 31, 2025Phase 3 trial completedA Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05633355
Jul 2, 2025Phase 1 trial completedA Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy ParticipantsClinicalTrials.gov NCT06438263
May 3, 2025Phase 1 main data collectedA Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy ParticipantsClinicalTrials.gov NCT06438263
Apr 11, 2025Phase 3 main data collectedA Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic DermatitisClinicalTrials.gov NCT06224192
Feb 27, 2025Phase 3 main data collectedA Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05704738
Feb 12, 2025Early Phase 1 trial completed · Basic-science trialStudy to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT05891119
Jan 13, 2025Phase 3 trial completedA Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)ClinicalTrials.gov NCT05398445
Dec 4, 2024Phase 3 trial completedA Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05724199
Nov 28, 2024Phase 3 main data collectedA Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)ClinicalTrials.gov NCT05398445
Nov 14, 2024Phase 3 trial completed · Basic-science trialA Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)ClinicalTrials.gov NCT05899816
Oct 8, 2024Phase 1 trial completedA Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy ParticipantsClinicalTrials.gov NCT06268860
Sep 15, 2024Phase 3 main data collectedA Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05724199
Aug 30, 2024Phase 1 main data collectedA Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy ParticipantsClinicalTrials.gov NCT06268860
Aug 28, 2024Early Phase 1 main data collected · Basic-science trialStudy to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT05891119
Aug 27, 2024Phase 3 trial completedA Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)ClinicalTrials.gov NCT05651711
Aug 26, 2024Phase 3 main data collected · Basic-science trialA Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)ClinicalTrials.gov NCT05899816
Aug 6, 2024Phase 1 trial startedA Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy ParticipantsClinicalTrials.gov NCT06438263
Jun 5, 2024Phase 1 trial completed · Basic-science trialA Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese ParticipantsClinicalTrials.gov NCT06214481
Jun 5, 2024Phase 3 main data collectedA Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)ClinicalTrials.gov NCT05651711
May 27, 2024Phase 1 main data collected · Basic-science trialA Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese ParticipantsClinicalTrials.gov NCT06214481
Apr 2, 2024Phase 3 trial startedA Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic DermatitisClinicalTrials.gov NCT06224192
Feb 15, 2024Phase 1 trial startedA Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy ParticipantsClinicalTrials.gov NCT06268860
Jan 23, 2024Phase 1 trial started · Basic-science trialA Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese ParticipantsClinicalTrials.gov NCT06214481
Jun 7, 2023Phase 3 trial started · Basic-science trialA Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)ClinicalTrials.gov NCT05899816
Jun 3, 2023Early Phase 1 trial started · Basic-science trialStudy to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT05891119
Apr 20, 2023Phase 3 trial startedA Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05704738
Feb 21, 2023Phase 3 trial startedA Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05724199
Jan 30, 2023Phase 3 trial startedA Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ClinicalTrials.gov NCT05633355
Dec 14, 2022Phase 3 trial startedA Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)ClinicalTrials.gov NCT05651711
Jun 9, 2022Phase 2 results postedStudy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT03703102
May 31, 2022Phase 3 trial startedA Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)ClinicalTrials.gov NCT05398445
Nov 12, 2020Phase 2 trial completedStudy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT03703102
Feb 6, 2020Phase 2 main data collectedStudy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT03703102
Oct 22, 2018Phase 2 trial startedStudy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic DermatitisClinicalTrials.gov NCT03703102