Eosinophilic DuodenitisPhase 3EoDysseyNCT04856891
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
A Phase 3 study testing AK002 in people with Eosinophilic Duodenitis and Eosinophilic Gastroenteritis, run by Allakos Inc. at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eosinophilic Duodenitis, Eosinophilic Gastroenteritis
- What is being tested?
- AK002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 39 sitesUnited States
- Study dates
- 20 May 2021to 9 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry.
- 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.
- Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
- 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.
- 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.
Show all 9Show fewer
- If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.
- Willing and able to comply with all study procedures and visit schedule including follow-up visits.
- 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.
Who cannot join
- Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day prednisone within 4 weeks prior to the screening visit.
- 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.
- Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit.
- Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
- Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
- 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.
Show all 21Show fewer
- History of inflammatory bowel disease, other chronic inflammatory diseases in the colon (with the exception of eosinophilic colitis), celiac disease, achalasia, or esophageal surgery.
- History of bleeding disorders and/or esophageal varices.
- Other causes of duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.
- Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
- 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.
- Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
- Positive helminthic infection on Ova and Parasite (O\&P) test.
- Seropositive for Strongyloides stercoralis at screening.
- Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening.
- 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.
- 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).
- Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant.
- Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Allakos Investigational Site
Austin, Texas, 78745
Allakos Investigational Site
Birmingham, Alabama, 35209
Allakos Investigational Site
Brandon, Florida, 33511
Allakos Investigational Site
Bristol, Connecticut, 06010
Allakos Investigational Site
Cedar Park, Texas, 78613
Allakos Investigational Site
Chattanooga, Tennessee, 37421
Allakos Investigational Site
Chula Vista, California, 91910
Allakos Investigational Site
Cincinnati, Ohio, 45219
Allakos Investigational Site
Cincinnati, Ohio, 45231
Allakos Investigational Site
Concord, North Carolina, 28027
Allakos Investigational Site
Crowley, Louisiana, 70526
Allakos Investigational Site
Dayton, Ohio, 45415
Allakos Investigational Site
Durham, North Carolina, 27710
Allakos Investigational Site
Edgewater, Florida, 32132
Allakos Investigational Site
Florham Park, New Jersey, 07932
Allakos Investigational Site
Fort Worth, Texas, 76104
Allakos Investigational Site
Fredericksburg, Virginia, 22401
Allakos Investigational Site
Gilbert, Arizona, 85234
Allakos Investigational Site
Great Neck, New York, 11023
Allakos Investigational Site
Greenwood, South Carolina, 29646
Allakos Investigational Site
Hamden, Connecticut, 06518
Allakos Investigational Site
Hermitage, Tennessee, 37076
Allakos Investigational Site
Hixson, Tennessee, 37343
Allakos Investigational Site
Jacksonville, Florida, 32256
Allakos Investigational Site
Kissimmee, Florida, 34741
Allakos Investigational Site
Lakewood Rch, Florida, 34211
Allakos Investigational Site
Lomita, California, 90717
Allakos Investigational Site
Lubbock, Texas, 79410
Allakos Investigational Site
Mentor, Ohio, 44094
Allakos Investigational Site
New Port Richey, Florida, 34653
Allakos Investigational Site
Ogden, Utah, 84405
Allakos Investigational Site
Ponte Vedra, Florida, 32081
Allakos Investigational Site
Reno, Nevada, 89511
Allakos Investigational Site
Salt Lake City, Utah, 84132
Allakos Investigational Site
San Antonio, Texas, 78229
Allakos Investigational Site
Sandy City, Utah, 84092
Allakos Investigational Site
Southlake, Texas, 76092
Allakos Investigational Site
Webster, Texas, 77598
Allakos Investigational Site
Wheat Ridge, Colorado, 80033
About this study
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
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.
- Being tested
- AK002, Placebo
- Keywords
- Eosinophil, Eosinophilic, Eosinophilic gastrointestinal disorders, EGID, EoD
- Medical subject headings
- Eosinophilic enteropathy, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK002Drug
Also called Lirentelimab
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 3.0 mg/kg of Lirentelimab (AK002) | Experimental | Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) at 3 mg/kg. Receives: Drug: AK002 |
| Placebo | Placebo comparator | Subjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Tissue Eosinophil Responders at Week 24
A tissue eosinophil responder is defined as mean eosinophil count <=15 cells/HPF in 3 duodenal HPFs
Measured: At Week 24
Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less- severe symptoms.
Measured: Baseline to Weeks 23 - 24
Secondary outcomes (6)
Percent Change in Tissue Eosinophils From Baseline to Week 24
Tissue eosinophil count obtained in biopsy specimens from the duodenum using esophago-gastro-duodenoscopy (EGD)
Measured: Baseline to Week 24
Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24
Tissue eosinophil count obtained in biopsy specimens from the duodenum using esophago-gastro-duodenoscopy (EGD)
Measured: At Week 24
Number of Treatment Responders
Treatment responders defined by >30% improvement in TSS and eosinophil count ≤15 cells per hpf in 3 duodenal hpf
Measured: At Weeks 23-24 and Week 24, Respectively
Subjects Who Achive ≥50% Reduction in TSS From Baseline to Weeks 23-24
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less- severe symptoms.
Measured: At Weeks 23-24
Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less- severe symptoms.
Measured: At Weeks 23-24
Percent Change in Weekly TSS Over Time Using MMRM
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less- severe symptoms.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start20 May 2021
- Primary completion14 Jun 2022
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic DuodenitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Paterson, MD, Study director, Allakos Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856891
- Sponsor's protocol ID
- AK002-021
- Acronym
- EoDyssey
- Status last verified
- Dec 2023
- First submitted
- 20 Apr 2021
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04856891
- Acronym / sponsor ID
- EoDyssey / AK002-021
- Keywords
- Eosinophil, Eosinophilic, Eosinophilic gastrointestinal disorders, EGID, EoD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3.0 mg/kg of Lirentelimab (AK002) | Experimental | Drug: AK002Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) at 3 mg/kg. |
| Placebo | Placebo comparator | Other: PlaceboSubjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent.
- Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry.
- 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.
- Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
- 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.
Key exclusion criteria (21 listed)
- Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day prednisone within 4 weeks prior to the screening visit.
- 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.
- Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit.
- Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
- Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK002Also: LirentelimabLirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8. | Drug | 3.0 mg/kg of Lirentelimab (AK002) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Proportion of Tissue Eosinophil Responders at Week 24
Time frame: At Week 24
A tissue eosinophil responder is defined as mean eosinophil count <=15 cells/HPF in 3 duodenal HPFs
Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24
Time frame: Baseline to Weeks 23 - 24
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less- severe symptoms.
6 secondary outcomes
Percent Change in Tissue Eosinophils From Baseline to Week 24
Time frame: Baseline to Week 24
Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24
Time frame: At Week 24
Number of Treatment Responders
Time frame: At Weeks 23-24 and Week 24, Respectively
Subjects Who Achive ≥50% Reduction in TSS From Baseline to Weeks 23-24
Time frame: At Weeks 23-24
Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24
Time frame: At Weeks 23-24
Percent Change in Weekly TSS Over Time Using MMRM
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Duodenitis
Active, not recruitingPhase 2
A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have
Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD)
Not yet recruiting
Umbilical Cord Blood Therapy in a Child With Eosinophilic Duodenitis and Autism Spectrum Disorder: a Case Study
Autism Spectrum Disorder, Eosinophilic Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Paterson, MD study director
Allakos Inc.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK002 in people with Eosinophilic Duodenitis and Eosinophilic Gastroenteritis, run by Allakos Inc. at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Tissue Eosinophil Responders at Week 24 (time frame: At Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.