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Evaluation of the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697069
Recruitment Status : Terminated (Administrative Reason)
First Posted : January 6, 2021
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Brief Summary:
Efficacy and Safety of ANB019 in Subjects with EGFRi/MEKi-Associated Acneiform Rash

Condition or disease Intervention/treatment Phase
Acneiform Eruptions Biological: ANB019 Biological: Placebo Phase 2

Detailed Description:
This study is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of ANB019 compared with placebo in cancer subjects with EGFRi/MEKi-associated acneiform rash. This study will also characterize the pharmacokinetic (PK) profile of ANB019 and explore the immune response to ANB019 in subjects with EGFRi/MEKi-associated acneiform rash.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Cancer Receiving EGFRi or MEKi Therapy
Actual Study Start Date : January 22, 2021
Actual Primary Completion Date : December 13, 2021
Actual Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: ANB019
Biological humanized monoclonal antibody
Biological: ANB019
Humanized Monoclonal Antibody
Other Name: Imsidolimab

Placebo Comparator: Placebo
Solution
Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in facial inflammatory lesion count [ Time Frame: Change from baseline to Week 8 ]
    Facial inflammatory lesion count measures the number of facial inflammatory lesions on the face.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has cancer
  • Subject is treated with an oral or injectable FDA-approved EGFRi or MEKi therapy
  • Subject has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per CTCAE Version 5.0, and ≥ 20 inflammatory lesions on the face at screening and Day 1.

Exclusion Criteria:

  • Subject has infected EGFRi/MEKi-associated acneiform rash according to Investigator's evaluation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697069


Locations
Show Show 18 study locations
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: Bruce Randazzo, MD AnaptysBio, Inc.
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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT04697069    
Other Study ID Numbers: ANB019-207
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnaptysBio, Inc.:
IL-36 receptor
Interluekin 36
Imsidolimab
Additional relevant MeSH terms:
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Acneiform Eruptions
Skin Diseases