A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis (KRYPTOS)
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| ClinicalTrials.gov Identifier: NCT04322708 |
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Recruitment Status :
Completed
First Posted : March 26, 2020
Results First Posted : January 2, 2024
Last Update Posted : January 2, 2024
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Sponsor:
Allakos Inc.
Information provided by (Responsible Party):
Allakos Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Eosinophilic Esophagitis |
| Interventions |
Other: Placebo Drug: lirentelimab (AK002) |
| Enrollment | 277 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Placebo | 1 mg/kg of Lirentelimab (AK002) | 3 mg/kg of Lirentelimab (AK002) |
|---|---|---|---|
 Arm/Group Description |
Subjects in this arm will receive 6 monthly doses of placebo. Placebo: Placebo |
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg). lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. |
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg. lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. |
| Period Title: Overall Study | |||
| Started | 92 | 93 | 91 |
| Completed | 89 | 89 | 85 |
| Not Completed | 3 | 4 | 6 |
Baseline Characteristics
| Arm/Group Title | AK002 1 mg/kg | AK002 3 mg/kg | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Patients randomized to 1, 1, 1, 1, 1, 1 mg/kg on Days 1, 29, 57, 85, 113, 141 | Patients randomized to 1, 3, 3, 3, 3, 3 mg/kg on Days 1, 29, 57, 85, 113, 141 | Patients randomized to placebo on Days, 1, 29, 57, 85, 113, 141 | Total of all reporting groups | |
| Overall Number of Baseline Participants | 93 | 91 | 92 | 276 | |
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Baseline Analysis Population Description |
Modified Intention-to-treat
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants | |
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34
(12 to 67)
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29
(12 to 69)
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32
(12 to 70)
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32
(12 to 70)
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants |
| <18 years |
17 18.3%
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17 18.7%
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17 18.5%
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51 18.5%
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|
| >=18 years |
76 81.7%
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74 81.3%
|
75 81.5%
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225 81.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants | |
| Female |
40 43.0%
|
26 28.6%
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37 40.2%
|
103 37.3%
|
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| Male |
53 57.0%
|
65 71.4%
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55 59.8%
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173 62.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants | |
| Hispanic or Latino |
8 8.6%
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5 5.5%
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9 9.8%
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22 8.0%
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| Not Hispanic or Latino |
84 90.3%
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82 90.1%
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82 89.1%
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248 89.9%
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| Unknown or Not Reported |
1 1.1%
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4 4.4%
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1 1.1%
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6 2.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants | |
| American Indian or Alaska Native |
0 0.0%
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1 1.1%
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0 0.0%
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1 0.4%
|
|
| Asian |
1 1.1%
|
0 0.0%
|
1 1.1%
|
2 0.7%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
1 1.1%
|
0 0.0%
|
1 0.4%
|
|
| Black or African American |
2 2.2%
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2 2.2%
|
5 5.4%
|
9 3.3%
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|
| White |
87 93.5%
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85 93.4%
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84 91.3%
|
256 92.8%
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| More than one race |
2 2.2%
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0 0.0%
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1 1.1%
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3 1.1%
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| Unknown or Not Reported |
1 1.1%
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2 2.2%
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1 1.1%
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4 1.4%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants |
| United States |
91 97.8%
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88 96.7%
|
88 95.7%
|
267 96.7%
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| Netherlands |
1 1.1%
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1 1.1%
|
1 1.1%
|
3 1.1%
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| Australia |
1 1.1%
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2 2.2%
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3 3.3%
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6 2.2%
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Baseline Esophageal Eosinophil Count
[1] Mean (Standard Deviation) Unit of measure: Eosinophils/HPF |
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| Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants | |
| 61.2 (35.3) | 58.9 (32.8) | 58.8 (32.8) | 59.7 (33.6) | ||
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[1]
Measure Description: Number of eosinophils per high power field (HPF) in esophageal mucosa
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Dysphagia Symptom Questionnaire (DSQ) Total Score
[1] Mean (Standard Deviation) Unit of measure: Score on a scale |
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| Number Analyzed | 93 participants | 91 participants | 92 participants | 276 participants | |
| 36.4 (12.0) | 34.2 (11.8) | 35.2 (12.1) | 35.3 (11.9) | ||
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[1]
Measure Description: The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Clinical Trial Agreement contains a limit on publication of results following completion of the trial. PIs are not allowed to publish results until a joint publication for the multicenter study or a set period of time. After that time, PIs may only publish results from their portion of the study.
Results Point of Contact
| Name/Title: | Medical Information |
| Organization: | Allakos |
| Phone: | 650-597-5002 |
| EMail: | medinfo@allakos.com |
| Responsible Party: | Allakos Inc. |
| ClinicalTrials.gov Identifier: | NCT04322708 |
| Other Study ID Numbers: |
AK002-014 |
| First Submitted: | March 24, 2020 |
| First Posted: | March 26, 2020 |
| Results First Submitted: | December 13, 2023 |
| Results First Posted: | January 2, 2024 |
| Last Update Posted: | January 2, 2024 |