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A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis (EoDyssey)

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: NCT04856891
Recruitment Status : Active, not recruiting
First Posted : April 23, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Allakos Inc.

Brief Summary:
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.

Condition or disease Intervention/treatment Phase
Eosinophilic Duodenitis Eosinophilic Gastroenteritis Drug: AK002 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) at 3 mg/kg.
Drug: AK002
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8.
Other Name: Lirentelimab

Placebo Comparator: Placebo
Subjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of Responders, where a responder is a patient achieving a mean peak duodenal eosinophil count ≤15 cells/3 duodenal hpf. [ Time Frame: At Week 24 ]
  2. Mean absolute change in 6 symptom total symptom score (TSS: abdominal pain, nausea, abdominal cramping, loss of appetite, fullness before finishing a meal, and bloating ) as measured by the PRO questionnaire (score from 0 none - 10 worst) [ Time Frame: Baseline to Weeks 23 - 24 ]

Secondary Outcome Measures :
  1. Percent change in tissue eosinophils [ Time Frame: Baseline to Week 24 ]
  2. Proportion of patients achieving peak duodenal intraepithelial eosinophil count of ≤1 eosinophil/hpf [ Time Frame: At Week 24 ]
  3. Number of treatment responders as defined by >30% improvement in symptoms and mean eosinophil count ≤15 cells/hpf in 3 duodenal hpf [ Time Frame: At Weeks 23-24 ]
  4. Proportion of patients who show ≥50% reduction in TSS [ Time Frame: Baseline to Weeks 23-24 ]
  5. Proportion of patients who show ≥70% reduction in TSS [ Time Frame: Baseline to Weeks 23-24 ]
  6. Percent change in weekly TSS over time [ Time Frame: Baseline to Weeks 23-24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent.
  2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry.
  3. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD + colonoscopy, without any other significant cause for the eosinophilia.
  4. Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
  5. A weekly average score of abdominal pain, nausea, or diarrhea ≥3 on the PRO questionnaire (score from 0-10) for at least 2 weeks of screening and a weekly average TSS of ≥10 for at least 2 weeks of screening.
  6. Inadequate or loss of response to, or intolerant to standard therapies for EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
  7. If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.
  8. Willing and able to comply with all study procedures and visit schedule including follow-up visits.
  9. Female patients must be either post-menopausal for at least 1 year with FSH level >30 MIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or later menstrual period) at any time during study participation.

Exclusion Criteria:

  1. Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day prednisone within 4 weeks prior to the screening visit.
  2. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 5 hpf in the gastric mucosa as determined by central histology assessment of biopsies collected during the screening EGD.
  3. Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit.
  4. Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
  5. Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
  6. Active Helicobacter pylori infection, unless treated and confirmed to be negative by repeat EGD (for baseline eosinophil count) prior to randomization and symptoms remain consistent.
  7. History of inflammatory bowel disease, other chronic inflammatory diseases in the colon (with the exception of eosinophilic colitis), celiac disease, achalasia, or esophageal surgery.
  8. History of bleeding disorders and/or esophageal varices.
  9. Other causes of duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis.
  10. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  11. Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.
  12. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
  13. History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, patients with cancers that have been in remission for more than 5 years and are considered cured can be enrolled.
  14. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
  15. Positive helminthic infection on Ova and Parasite (O&P) test.
  16. Seropositive for Strongyloides stercoralis at screening.
  17. Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening.
  18. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. This exclusion criterion does not apply to all types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19, which may be administered before, during, or after the study.
  19. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).
  20. Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant.
  21. Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.

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): NCT04856891


Locations
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United States, Alabama
Allakos Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Allakos Investigational Site
Gilbert, Arizona, United States, 85234
United States, California
Allakos Investigational Site
Chula Vista, California, United States, 91910
Allakos Investigational Site
Lomita, California, United States, 90717
United States, Colorado
Allakos Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Allakos Investigational Site
Bristol, Connecticut, United States, 06010
Allakos Investigational Site
Hamden, Connecticut, United States, 06518
United States, Florida
Allakos Investigational Site
Brandon, Florida, United States, 33511
Allakos Investigational Site
Edgewater, Florida, United States, 32132
Allakos Investigational Site
Jacksonville, Florida, United States, 32256
Allakos Investigational Site
Kissimmee, Florida, United States, 34741
Allakos Investigational Site
Lakewood Ranch, Florida, United States, 34211
Allakos Investigational Site
New Port Richey, Florida, United States, 34653
Allakos Investigational Site
Ponte Vedra, Florida, United States, 32081
United States, Louisiana
Allakos Investigational Site
Crowley, Louisiana, United States, 70526
United States, Nevada
Allakos Investigational Site
Reno, Nevada, United States, 89511
United States, New Jersey
Allakos Investigational Site
Florham Park, New Jersey, United States, 07932
United States, New York
Allakos Investigational Site
Great Neck, New York, United States, 11023
United States, North Carolina
Allakos Investigational Site
Concord, North Carolina, United States, 28027
Allakos Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Allakos Investigational Site
Cincinnati, Ohio, United States, 45219
Allakos Investigational Site
Cincinnati, Ohio, United States, 45231
Allakos Investigational Site
Dayton, Ohio, United States, 45415
Allakos Investigational Site
Mentor, Ohio, United States, 44094
United States, South Carolina
Allakos Investigational Site
Greenwood, South Carolina, United States, 29646
United States, Tennessee
Allakos Investigational Site
Chattanooga, Tennessee, United States, 37421
Allakos Investigational Site
Hermitage, Tennessee, United States, 37076
Allakos Investigational Site
Hixson, Tennessee, United States, 37343
United States, Texas
Allakos Investigational Site
Austin, Texas, United States, 78745
Allakos Investigational Site
Cedar Park, Texas, United States, 78613
Allakos Investigational Site
Fort Worth, Texas, United States, 76104
Allakos Investigational Site
Lubbock, Texas, United States, 79410
Allakos Investigational Site
San Antonio, Texas, United States, 78229
Allakos Investigational Site
Southlake, Texas, United States, 76092
Allakos Investigational Site
Webster, Texas, United States, 77598
United States, Utah
Allakos Investigational Site
Ogden, Utah, United States, 84405
Allakos Investigational Site
Salt Lake City, Utah, United States, 84132
Allakos Investigational Site
Sandy, Utah, United States, 84092
United States, Virginia
Allakos Investigational Site
Fredericksburg, Virginia, United States, 22401
Sponsors and Collaborators
Allakos Inc.
Investigators
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Study Director: Craig Paterson, MD Allakos Inc.
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Responsible Party: Allakos Inc.
ClinicalTrials.gov Identifier: NCT04856891    
Other Study ID Numbers: AK002-021
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Allakos Inc.:
Eosinophil
Eosinophilic
Eosinophilic gastrointestinal disorders
EGID
EoD
Additional relevant MeSH terms:
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Gastroenteritis
Eosinophilic Esophagitis
Duodenitis
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Esophageal Diseases
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Enteritis
Duodenal Diseases
Intestinal Diseases