AMGEN - MODERATE TO SEVERE ATOPIC DERMATITIS


Protocol

AMGEN 20210143

Research Study Summary

<p>Study to Assess the Efficacy, Safety and Tolerability of <strong>Rocatinlimab</strong>&nbsp;&nbsp;(AMG451)&nbsp; Monotherapy in Adult Subjects With Moderate-to-Severe Atopic Dermatitis.</p> <p>Number of Visits: 9&nbsp;</p> <p>Duration of the Study: 6 months</p>

Eligibility

Inclusion Criteria:

<p>Age 18 &gt; years.</p> <p>Patient has a diagnosis of Atopic Dermatitis</p> <p>&gt; 10% Body surface</p> <p>Other conditions apply</p> <p>&nbsp;</p> <p>&nbsp;</p>

Exclusion Criteria:

<ol> <li>Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma)</li> <li>&nbsp;History of major immunologic reaction.</li> <li>Evidence of human immunodeficiency virus (HIV) infection.</li> <li>Positive for hepatitis C virus (HCV) antibody.</li> <li>Severe depression, poorly controlled schizophrenia.</li> <li>History of suicide attempts.</li> <li>Treatment with biological immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic diseases&nbsp; ( eg. dupilumab, tralokinumab, lebrikizumab, other interleukin inhibitors, anti-immunoglobulin E [lgE], TNF inhibitors) Within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.&nbsp;</li> <li>Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.</li> </ol> <ul> <li>Systemic corticosteroids.</li> </ul> <p>Systemic treatment with methotrexate mycophenolate, calcineurin inhibitors, thalidomide, or other systemic immunosuppressants.</p> <p><strong>Others Exclusions</strong></p> <p>Female patients of childbearing potential are unwilling to use the protocol-specified method of contraception.</p> <p>&nbsp;</p>

Additional Information:

<p>You will receive a fixed fee reimbursement of $50.00 for every visit to cover inconvenience, for up to 10 visits for a total of $500.00. Payments will be made through Clincard, after each completed visit.</p> <p>Additional travel costs will be reimbursed per the following rates:</p> <ul> <li>Taxi up to $50.00 per trip or</li> <li>Public transit up to 50.00 or</li> <li>Drive/Mileage $0.58 per mile up to $116.00 per visit and Tolls/ Parking: Up to $50.00 per visit.</li> </ul> <p>Long-distance travel only:</p> <ul> <li>Train: $100.00 per round trip</li> <li>Flights: $500.00 per round trip</li> <li>Hotel: $250.00 per night, maximum 1 night to be reimbursed to subject traveling long distances.</li> <li>Meals: up to $20.00 per meal/ request, to be reimbursed to subjects traveling long distances that require hotel accommodation</li> <li>If you are traveling long distances, you will be reimbursed for reasonable out-of-pocket expenses including hotel/travel/parking.</li> </ul> <p>&nbsp;</p>

Study Location

Integral Clinical Trials Solutions
700 N Hiatus Rd
Suite 213
Pembroke Pines, Florida 33026
info@integralcts.com

Contact Number

786-908-5827 ext. 555-666-0606

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