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ROCKET-SHUTTLE: A Study Assessing Rocatinlimab in Combination with Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants with Moderate-to-Severe Atopic Dermatitis
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Study Assessing Rocatinlimab in Combination with Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants with Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
 
Region Sponsors
California - Northern
Amgen
 
Acronym KP IRB No.
KPNC-1985294
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Female and Male: Age = 18 years at signing of informed consent.
 
Purpose
This is a phase 3, 24-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of rocatinlimab in combination with TCS/TCI in adult subjects with moderate-to-severe AD with inadequate response to topical medications.
 
Detailed Description
This study is designed io evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-ADâ„¢). This study will also evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Subject has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age = 18 years at signing of informed consent.
  • Subject has a diagnosis of Atopic Dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 6 months before signing of informed consent.
  • Prior to informed consent, history of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI as appropriate).
 
Exclusion Criteria
  • 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).
  • History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab.
  • Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.
  • Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at initial screening or current acquired, common variable or inhibited, primary or secondary immunodeficiency.
  • Positive for hepatitis C virus (HCV) antibody at initial screening with confirmed positive HCV RNA.

 
Keywords and/or Specific Medical Conditions
  • Atopic Dermatitis
  • Internal Medicine
  • Dermatology
 
KP Clinical Facility
  • Oakland Medical Center
  • San Francisco Medical Center
  • South Sacramento Medical Center
 
Clinical Area
  • Dermatology
  • Internal Medicine


Principal Investigator:
Paradi Mirmirani, MD
Contact Information:
- Marina Rumore
-Marina.M.Rumore@kp.org
-Oakland Medical Center


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