CompletedPhase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002

Germany25 participantsStarted 2016-06

Plain-language summary

This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with indolent systemic mastocytosis (ISM).

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Provided written informed consent
✓. Male or female aged ≥18 and ≤65 years at the time of signing the informed consent form
✓. Confirmed diagnosis of ISM based on World Health Organization (WHO) criteria (Appendix 1)
✓. Presence of at least 1 of the following SM related symptoms:
✓. Flushing (at least 1 episode per week)
✓. Pruritus (minimum MAS2 score of 4) (Appendix 2)
✓. Diarrhea (minimum MAS2 score of 4) (Appendix 2)
✓. Anaphylaxis (at least 1 episode \[grade 2 or higher\] within the last 12 months)

✕. Known hypersensitivity to any constituent of the study drug
✕. Presence of an associated hematologic non-mast-cell lineage disorder or MC leukemia
✕. Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of AK002, or would place the patient at increased risk
✕. The presence of abnormal laboratory values considered to be clinically significant by the Investigator
✕. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (90 days or 5 half-lives, whichever is longer, for biologic products)
✕. Treatment with chemotherapy or radiotherapy in the preceding 6 months
✕. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening
✕. Use during the 7 days before Screening (or 5 half-lives, whichever is longer) or expected to require the use of angiotensin converting enzyme (ACE) inhibitors or beta blockers

To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4

Timeframe: From study start to Day 85 or early term visit

NCT IDNCT02808793

SponsorAllakos Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Provided written informed consent
✓. Male or female aged ≥18 and ≤65 years at the time of signing the informed consent form
✓. Confirmed diagnosis of ISM based on World Health Organization (WHO) criteria (Appendix 1)
✓. Presence of at least 1 of the following SM related symptoms:
✓. Flushing (at least 1 episode per week)
✓. Pruritus (minimum MAS2 score of 4) (Appendix 2)
✓. Diarrhea (minimum MAS2 score of 4) (Appendix 2)
✓. Anaphylaxis (at least 1 episode \[grade 2 or higher\] within the last 12 months)

✕. Known hypersensitivity to any constituent of the study drug
✕. Presence of an associated hematologic non-mast-cell lineage disorder or MC leukemia
✕. Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of AK002, or would place the patient at increased risk
✕. The presence of abnormal laboratory values considered to be clinically significant by the Investigator
✕. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (90 days or 5 half-lives, whichever is longer, for biologic products)
✕. Treatment with chemotherapy or radiotherapy in the preceding 6 months
✕. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening
✕. Use during the 7 days before Screening (or 5 half-lives, whichever is longer) or expected to require the use of angiotensin converting enzyme (ACE) inhibitors or beta blockers