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Monoclonal Antibodies
Rocatinlimab for Atopic Dermatitis/Eczema (ROCKET-ASCEND Trial)
Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 116 weeks
Awards & highlights
ROCKET-ASCEND Trial Summary
This trial looks at how safe and tolerable a drug is for people with moderate-to-severe atopic dermatitis over a long-term.
Who is the study for?
This trial is for adults and adolescents with moderate-to-severe atopic dermatitis (AD), commonly known as eczema, who have completed a previous rocatinlimab study within the last 28 days. It's not open to those who had to stop taking the drug due to safety concerns or other rules from earlier studies.Check my eligibility
What is being tested?
The trial is testing the long-term effects of a medication called Rocatinlimab on AD. Participants will either continue receiving Rocatinlimab or be given a placebo, which has no active ingredients, to compare outcomes over time.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to Rocatinlimab since understanding its long-term safety and tolerability in treating AD is the main goal of this study.
ROCKET-ASCEND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 116 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 116 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events
Secondary outcome measures
Maintaining EASI 75 Response Among Participants Achieving EASI 75 Response at Day 1
Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1
Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1
+3 moreSide effects data
From 2018 Phase 2 trial • 66 Patients • NCT0264786614%
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-ASCEND Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1Experimental Treatment1 Intervention
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 be assigned to receive OL Rocatinlimab Dose 1 Q4W.
Group II: ARM B: Dose 2 to Dose 2Experimental Treatment1 Intervention
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.
Group III: ARM A: Dose 1 to Dose 1Experimental Treatment1 Intervention
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.
Group IV: ARM D: Placebo to PlaceboPlacebo Group1 Intervention
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.
Group V: ARM C: Dose 1 or Dose 2 to PlaceboPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,376,018 Total Patients Enrolled
MDStudy DirectorAmgen
915 Previous Clinical Trials
922,530 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have finished the final study visit for a previous study involving the drug rocatinlimab within the last 28 days.I was removed from a previous study due to safety concerns or other specific reasons.
Research Study Groups:
This trial has the following groups:- Group 1: ARM A: Dose 1 to Dose 1
- Group 2: ARM D: Placebo to Placebo
- Group 3: ARM B: Dose 2 to Dose 2
- Group 4: ARM C: Dose 1 or Dose 2 to Placebo
- Group 5: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial still open to enrollees?
"As indicated on clinicaltrials.gov, the recruitment phase of this medical trial is ongoing; it was first posted on May 31st 2023 and updated lastly on June 5th 2023."
Answered by AI
Has the FDA sanctioned ARM B: Dose 2 to Dose 2 for therapeutic use?
"Dedicated analysis by the Power team concluded that ARM B: Dose 2 to Dose 2 is a secure intervention, rating it 3 on their scale. This was due to multiple rounds of testing attesting efficacy and safety in Phase 3 trials."
Answered by AI
Is this clinical trial open to persons aged under fifty years?
"To be admitted to this trial, the participant must fall between 12 and 100 years of age. 97 individuals under 18 have already been recruited while 155 seniors are currently involved in the study."
Answered by AI
Are there any specific characteristics that would make a person an ideal candidate for this clinical trial?
"In order to meet the criteria of this medical trial, participants must have atopic dermatitis and be older than 12 but younger than 100. The purpose is to recruit a total of 2200 people for study."
Answered by AI
What is the cap on participant numbers for this trial?
"Affirmative. Data available on clinicaltrials.gov reveals that this medical trial, which was initially posted May 31st 2023, is presently recruiting participants. In total 2200 people are required between two sites."
Answered by AI
Who else is applying?
What site did they apply to?
Oregon Medical Research Center
Unity Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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