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Indolent Systemic MastocytosisPhase 1NCT02808793

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

A Phase 1 study testing AK002 in people with Indolent Systemic Mastocytosis, run by Allakos Inc. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Indolent Systemic Mastocytosis
What is being tested?
AK002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteGermany
Study dates
Jun 2016to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • Diarrhea (minimum MAS2 score of 4) (Appendix 2)
  • Anaphylaxis (at least 1 episode [grade 2 or higher] within the last 12 months)
  • Serum total tryptase exceeded 15 ng/mL* at 2 or more measurements obtained 1 or more months apart within the last 2 years (*Note: this varies from the minor criterion of "persistently exceeds 20 ng/mL" in the WHO criteria for diagnosis of ISM)
  • Willing and able to comply with the study procedures and visit schedule, including follow-up visits
  • Able to communicate effectively with the study site personnel
  • Negative Screening urine drug tests (alcohol, amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, methadone, methaqualone, opiates, phencyclidine)
  • Negative Screening ova and parasite test
  • Determined by the Investigator to be in good health as documented by the medical history, physical examination (PE), vital sign assessments, 12- lead ECG, clinical laboratory assessments, and by general observations
  • Women of child bearing potential, must be using highly effective methods of birth control (failure rate <1% per year when used consistently and correctly) at least 4 weeks prior to Screening until Day 85. Women should be informed of the potential risks associated with becoming pregnant while enrolled. Accepted forms of contraception are implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs). In addition, a barrier method must always be used concomitantly to the highly effective method. Double-barrier is not considered a highly effective method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not an acceptable means of contraception. Female patients are considered to not be of child-bearing potential when they are post-menopausal for at least 2 years with follicle-stimulating hormone (FSH) levels >40 mIU/mL, are surgically sterilized, or have undergone hysterectomy.
  • Male patients with female partners of childbearing potential must agree to use a condom without spermicide during sexual activity with female partners of childbearing potential. Female sexual partners of male patients must be willing to avoid pregnancy according to the above described methods.

Who cannot join

  • 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
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  • 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
  • Use during the 30 days before Screening (or 5 half lives, whichever is longer) or expected to require the use of omalizumab, immunosuppressive drugs, or systemic corticosteroids with a daily dose >10 mg prednisone or equivalent
  • 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 the study drug administration
  • Donation or loss of >500 mL of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of study drug
  • Has not refrained from excessive caffeine consumption (>3 cups of coffee per day or equivalent) for 48 hours prior to study drug administration and agreed to this do so throughout the inpatient period
  • Positive hepatitis serology results, except for vaccinated patients or patients with past but resolved hepatitis, at Screening
  • Positive HIV serology results at Screening
  • Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment
  • Patient is vulnerable (e.g., patient kept in detention)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin Berlin

    Berlin

Other trials in Germany

About this study

Official title: A Phase 1, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002 in Patients With Indolent Systemic Mastocytosis

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

Being tested
AK002
Keywords
ISM, Mastocytosis, Indolent Mastocytosis
Medical subject headings
Mastocytosis, Systemic, Mastocytosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK002Drug

Study groups in NCT02808793
Study groupRoleWhat they receive
AK002ExperimentalIV dose of AK002
Receives: Drug: AK002

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

  1. Evaluate PK of AK002 in patients with ISM

    Measured: Through out the study from baseline to Day 85 or early term visit

  2. Evaluate the change from baseline in absolute peripheral counts of eosinophils and basophils.

    Measured: Through out the study from screening to Day 85 or early term visit

  3. Evaluate the change from baseline in serum tryptase and eosinophil grande protein levels.

    Measured: Through out the study from screening to Day 29 or early term visit

  4. Measure changes form baseline in the 24-hour urine histamine metabolites.

    Measured: Starting pre dose on day -1 to days 1, 3 and 4

  5. Mastocytosis Quality of Life Questionnaire

    Measured: Through out the study from screening to Day 85 or early term visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02808793
Sponsor's protocol ID
AK002-001
Status last verified
Mar 2019
First submitted
16 Jun 2016
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK002 in people with Indolent Systemic Mastocytosis, run by Allakos Inc. at 1 site in Germany.

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 16 inclusion and 16 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4 (time frame: From study start to Day 85 or early term visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808793.

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 13 Mar 2019.

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