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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Horizon Trial)

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights

ROCKET-Horizon Trial Summary

This trial compares a new drug to placebo to see if it helps reduce eczema symptoms.

Who is the study for?
This trial is for adults with moderate-to-severe atopic dermatitis (AD) who haven't responded well to medium or stronger topical corticosteroids, or when such treatments are not advised. Participants must have a significant itch, extensive rash covering at least 10% of their body, and meet specific severity scores on AD scales.Check my eligibility
What is being tested?
The study tests Rocatinlimab's effectiveness against a placebo in improving AD symptoms by week 24. It uses two measures: the vIGA-AD scale assessing overall disease severity and the EASI score evaluating rash area and intensity.See study design
What are the potential side effects?
While specific side effects for Rocatinlimab aren't listed here, common ones for new AD therapies may include injection site reactions, potential immune system changes leading to increased infection risk, headaches, eye irritation or inflammation.

ROCKET-Horizon Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Secondary outcome measures
Achievement of EASI 75 at Week 16
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8
+25 more

Side effects data

From 2018 Phase 2 trial • 66 Patients • NCT02647866
14%
Anaemia
12%
Pyrexia
10%
Colitis ulcerative
6%
Chills
6%
Abdominal pain
6%
Arthralgia
4%
Lymphopenia
4%
Mouth ulceration
4%
Sinusitis
4%
Blood creatine phosphokinase increased
4%
Headache
2%
Cough
2%
Colitis
2%
Thrombocytosis
2%
Abdominal pain upper
2%
Diarrhoea
2%
Flatulence
2%
Mucous stools
2%
Pharyngitis
2%
Urinary tract infection
2%
Joint swelling
2%
Oropharyageal pain
2%
Sneezing
2%
Pruritis
2%
Myocardial infarction
2%
Clostridium difficile infection
2%
Pneumonia
2%
Post procedural infection
2%
Blood albumin decreased
2%
Nausea
2%
Chest discomfort
2%
Scar
2%
Blood folate decreased
2%
C-reactive protein increased
2%
Asthenia
2%
Myalgia
2%
Paraesthesia
2%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
KHK4083 Combined
Placebo
KHK4083 Cohort 1
KHK4083 Cohort 2
KHK4083 Cohort 3
KHK4083 Cohort 4

ROCKET-Horizon Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RocatinlimabExperimental Treatment1 Intervention
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Group II: PlaceboPlacebo Group1 Intervention
Placebo Q4W for 24 weeks with a loading dose at Week 2.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,376,962 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,405 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05651711 — Phase 3
Atopic Dermatitis Research Study Groups: Rocatinlimab, Placebo
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05651711 — Phase 3
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651711 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors over the age of 85 able to partake in this experimentation?

"As specified by the clinical trial's inclusion criteria, only patients aged 18-100 are eligible. Separately, 102 trials and 168 trials have been created for individuals younger than 18 and over 65 respectively."

Answered by AI

Has enrollment for this therapeutic trial been opened up?

"Correct. The information posted on clinicaltrials.gov affirms that this medical trial, first published on December 14th 2022, is still recruiting patients. Approximately 680 individuals need to be enrolled from 6 differing locations."

Answered by AI

Has Rocatinlimab been endorsed by the FDA?

"Rocatinlimab has been assessed with a rating of 3 due to the presence of data evidencing its efficacy and multiple iterations of safety-related research."

Answered by AI

Are there numerous facilities offering this trial in the North American region?

"Patients wishing to take part in this clinical trial can enrol at Clinical Science Institute (Santa Monica, California), St. Jude Clinical Research (Doral, Florida) and Kentucky Advanced Medical Research LLC (Murray, Kentucky). There are 6 other additional sites taking patients as well."

Answered by AI

What is the aggregate amount of participants enrolled in this trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively seeking individuals for its study; it was initially announced on December 14th 2022 and underwent a recent alteration on the 16th of that same month. 680 participants are needed from 6 distinct locations."

Answered by AI

Do I meet the prerequisites to partake in this medical experiment?

"This trial requires 680 adults (18 and above) with a 6-month history of dermatitis that has proven ineffective to mid or higher potency topical corticosteroids, as well as an EASI score ≥16, vIGA-AD score≥3, worst pruritus numerical rating scale ≥4, and BSA involvement of at least 10%."

Answered by AI

Who else is applying?

What site did they apply to?
Innovation Medical Research Center Inc
Center for Dermatology and Plastic Surgery
Other
Weiss Medical
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have had eczema since age 5 ..used many biologicals and JAK inhibitors with Dr Brett King at Yale New Haven . I have a long standing hx if eisinophillia and extremely elevated IGE even on immunotherapy.
PatientReceived 1 prior treatment
~81 spots leftby Jul 2024