Rocatinlimab for Atopic Dermatitis

Icahn School of Medicine at Mount Sinai, New York, NY
Atopic DermatitisRocatinlimab - Drug
Eligibility
12 - 17
All Sexes

Study Summary

This trial tests a drug's safety and effectiveness in teens with moderate-to-severe eczema.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 52 Weeks

Baseline and Week 24
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline and Presence of Barely Perceptible Erythema or No Erythema at Week 24
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Up to 52 Weeks
Number of Participants With Treatment-emergent Serious Adverse Events

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Rocatinlimab
1 of 1

Experimental Treatment

170 Total Participants · 1 Treatment Group

Primary Treatment: Rocatinlimab · No Placebo Group · Phase 3

Rocatinlimab
Drug
Experimental Group · 1 Intervention: Rocatinlimab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 52 weeks

Who is running the clinical trial?

AmgenLead Sponsor
1,311 Previous Clinical Trials
1,336,496 Total Patients Enrolled
MDStudy DirectorAmgen
848 Previous Clinical Trials
900,975 Total Patients Enrolled

Eligibility Criteria

Age 12 - 17 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with AD (a skin condition) according to specific medical criteria for at least 6 months prior to agreeing to participate in the study.

Frequently Asked Questions

Does this research welcome participants younger than 75 years old?

"The conditions for enrolment in the present trial necessitate that participants must be between 12 and 17 years old. Moreover, there are 104 clinical trials offered to minors and 170 studies open to elderly individuals over 65." - Anonymous Online Contributor

Unverified Answer

What adverse effects have been reported as a result of taking Rocatinlimab?

"Our team has concluded that rocatinibimab is a safe intervention, awarding it the highest possible rating of 3. This determination was made based on prior evidence demonstrating its efficacy and numerous studies confirming its safety profile." - Anonymous Online Contributor

Unverified Answer

How many venues are facilitating this research endeavor?

"Currently, prospective participants can register for this trial at 5 distinct sites across the US. These locations are in Portland, Corpus Christi and Dallas to name a few. To minimize travel costs associated with participating, it is best to select the clinic closest you." - Anonymous Online Contributor

Unverified Answer

What is the size of the cohort enrolled in this clinical research?

"This research trial necessitates the enrolment of 170 suitable individuals. Potential participants can take part at either Oregon Medical Research Center in Portland or Driscoll Childrens Hospital located in Corpus Christi, Texas." - Anonymous Online Contributor

Unverified Answer

Is there still room to enroll participants in this trial?

"Affirmative, according to the information hosted on clinicaltrials.gov this experiment is recruiting participants as of now. The trial was initially posted on January 30th 2023 and modified most recently on February 3rd 2023. It seeks 170 volunteers from 5 different medical centers." - Anonymous Online Contributor

Unverified Answer

Is there a predetermined criteria for participation in this research?

"This clinical trial is selecting 170 juvenile patients with atopic dermatitis to participate. The selection criteria necessitates that candidates are between the ages of 12 and 17, have had diagnosis for a minimum 6 months, demonstrate inadequate response to topical corticosteroid therapy in combination or not with TCI's, an EASI score exceeding 16 points and vIGA-AD score above 3 as well as more than 10% BSA affected by AD at enrollment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.