← Back to Search

Monoclonal Antibodies

Rocatinlimab for Eczema

Q: Does this trial extend to individuals aged over thirty?

The lower age limit to join this clinical trial is 18 and the upper age cap has been set at 65.

Q: Is this clinical research currently admitting individuals to participate?

Based on the information found on clinicaltrials.gov, this trial is actively recruiting participants and was first announced in early June of 2023 with a subsequent update posted later that month.

Q: How many subjects are currently being monitored as part of this experiment?

Affirmative. The information readily available on clinicaltrials.gov indicates that enrolment is currently in progress for this trial, which was first posted on June 3rd 2023 and most recently modified on June 19th 2023. This research project requires the recruitment of approximately twenty participants from two distinct locations.

Q: Who is capable of participating in this experiment?

To be eligible for the trial, individuals must have <a href="https://www.withpower.com/clinical-trials/atopic-dermatitis">atopic dermatitis</a> and fall between 18 to 65 years of age. Approximately 20 people are being accepted into this study.

Phase < 1

Recruiting

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 up to day 238

Awards & highlights

Study Summary

This trial tests how different drugs interact with rocatinib to treat moderate to severe eczema.

Who is the study for?

Adults aged 18-65 with moderate to severe atopic dermatitis (AD) who haven't responded well to topical corticosteroids can join. They must have a significant area of skin affected and certain severity scores. Excluded are those with immune deficiencies, recent drug abuse, specific dietary habits before check-in, or use of conflicting medications.Check my eligibility

What is being tested?

The trial is testing how the body processes common drugs when taken alone versus alongside Rocatinlimab in people with AD. It's looking at Warfarin (a blood thinner), Metoprolol (for high blood pressure), Caffeine, Midazolam (a sedative), Omeprazole (for acid reflux), and Vitamin K.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to Rocatinlimab, as well as typical side effects from the other study drugs like bleeding risks from Warfarin or drowsiness from Midazolam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 238

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 238

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 238 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUCinf of CYP450 Substrate

AUClast of CYP450 Substrate

Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUCinf) of CYP450 Substrate

+3 more

Secondary outcome measures

Number of Participants with Anti-rocatinlimab Antibody Formation

Number of Participants with Serious Adverse Events (SAEs)

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rocatinlimab and CYP450 SubstratesExperimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

2018

Completed Phase 4

~1910

Warfarin

2017

Completed Phase 4

~248220

Caffeine

2014

Completed Phase 3

~2980

Metoprolol

2006

Completed Phase 4

~3730

Omeprazole

2006

Completed Phase 4

~940

Vitamin K

2016

Completed Phase 4

~570

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,378,198 Total Patients Enrolled

MDStudy DirectorAmgen

915 Previous Clinical Trials

924,710 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05891119 — Phase < 1

Atopic Dermatitis Research Study Groups: Rocatinlimab and CYP450 Substrates

Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05891119 — Phase < 1

Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05891119 — Phase < 1

Frequently Asked Questions

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

Does this trial extend to individuals aged over thirty?

"The lower age limit to join this clinical trial is 18 and the upper age cap has been set at 65."

Answered by AI

Is this clinical research currently admitting individuals to participate?

"Based on the information found on clinicaltrials.gov, this trial is actively recruiting participants and was first announced in early June of 2023 with a subsequent update posted later that month."

Answered by AI

How many subjects are currently being monitored as part of this experiment?

"Affirmative. The information readily available on clinicaltrials.gov indicates that enrolment is currently in progress for this trial, which was first posted on June 3rd 2023 and most recently modified on June 19th 2023. This research project requires the recruitment of approximately twenty participants from two distinct locations."

Answered by AI

Who is capable of participating in this experiment?

"To be eligible for the trial, individuals must have atopic dermatitis and fall between 18 to 65 years of age. Approximately 20 people are being accepted into this study."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I have tried just about every biologic and 3 different JAK inhibitors (for alopecia universalis)in addition to my severe eczema. Currently on Cibinqo 200 mg BID.

PatientReceived no prior treatments