A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT03496571
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: Allakos Inc.
• Public title: A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis ENIGMA
• Scientific title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
• Date of first enrolment: July 18, 2018
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03496571
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Henrik Rasmussen, MD, PhD
• Affiliation: Allakos Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female aged =18 and =80 years at the time of signing ICF.

2. Average weekly score of =3 (on a scale from 0-10, recorded for either abdominal pain,
diarrhea and/or nausea on the PRO questionnaire during at least 2 out of 3 weeks of
PRO collection. A minimum of four questionnaires must be completed each qualifying
week.

3. Eosinophilia of the gastric mucosa =30 eosinophils/HPF in 5 HPFs and/or eosinophilia
of the duodenal mucosa =30 eosinophils/HPF in 3 HPFs from the EGD performed during the
screening period, without any other cause for the gastric eosinophilia (e.g.,
parasitic or other infection or malignancy).

4. Subjects must have failed or not be adequately controlled on standard-of-care
treatments for EG or EGE symptoms (which could include PPIs, systemic or topical
corticosteroids, and/or diet, among others).

5. If on other treatments for EG, EGE, or EoE at enrollment, stable dose for at least 5
half-lives prior to screening and willingness to continue on that dose for the
duration of the study.

6. If subject is on pre-existing dietary restrictions, willingness to maintain dietary
restrictions throughout the study, as much as possible.

7. Able and willing to comply with all study procedures.

8. Female subjects must be either post-menopausal for at least 1 year with FSH level >40
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 subjects 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 at any time during study participation.

Exclusion Criteria:

1. Known hypersensitivity to any constituent of the study drug.

2. Diagnosis of celiac disease or H. pylori infection as determined by screening EGD or a
history of celiac disease diagnosed by prior EGD.

3. Presence of abnormal laboratory values considered by the Investigator to be clinically
significant.

4. Grade 2 or higher lymphopenia (<0.8 × 109/L lymphocytes).

5. Any disease or condition (medical or surgical) or cardiac abnormality, which, in the
opinion of the Investigator, would place the subject at increased risk.

6. History of malignancy; except carcinoma in situ in the cervix, early stage prostate
cancer, or non-melanoma skin cancers. However, cancers that have been in remission for
more than 5 years and are considered cured, can be enrolled (with the exception of
breast cancer). All history of malignancy (including diagnosis, dates, and compliance
with cancer screening recommendations) must be documented and certified by the
Investigator, along with the statement that in their clinical judgment the tissue
eosinophilia is attributable to EGID, rather than recurrence of malignancy.

7. Treatment with chemotherapy or radiotherapy in the preceding 6 months.

8. Treatment for a clinically significant helminthic parasitic infection within 6 months
of screening and/or a positive helminthic test at screening.

9. Use of any medications that may interfere with the study such as immunosuppressive or
immunomodulatory drugs (including azathioprine, 6-mercaptopurine, methotrexate,
cyclosporine, tacrolimus, anti-TNF, anti-IL-5, anti-IL-5 receptor, dupilumab, anti-IgE
antibodies, omalizumab) or systemic corticosteroids with a daily dose >10 mg of
prednisone or equivalent, during 5 half-lives prior to screening or during the
screening period, except for omalizumab taken in asthma and/or urticaria patients
where their asthma and/or urticaria cannot be controlled on other medications. In such
cases, the dose of omalizumab should remain stable during screening and throughout the
study.

10. 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 of the study drug administration.

11. Known history of alcohol, drug, or other substance abuse or dependence.

12. Participation in a concurrent interventional study with the last intervention
occurring within 30 days prior to administration of study drug (or 90 days or 5
half-lives, whichever is longer, for biologic products).

13. Women who are pregnant, breastfeeding, or planning to become pregnant while
participating in the study.

14. Any other reason that in the opinion of the Investigator or Medical Monitor makes the
patient unsuitable for enrollment.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Gastritis

Eosinophilic Gastroenteritis

Intervention(s)

Drug: AK002

Other: Placebo

Primary Outcome(s)

Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline [Time Frame: Baseline to Day 99]

Secondary Outcome(s)

Percent Change in PRO Total Symptom Score (TSS) From Baseline [Time Frame: Baseline to Days 85-99]

Number of Treatment Responders [Time Frame: On Days 85-99 and Day 99, respectively]

Secondary ID(s)

AK002-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/01/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03496571