Celiac DiseasePhase 1NCT04248855

Assessment of KAN-101 in Celiac Disease (ACeD)

A Phase 1 study testing KAN-101 in people with Celiac Disease, run by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA at 13 sites in United States.

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

A safety study of KAN-101 in patients with celiac disease. The study has two parts: 1. Part A - first in human study in which patients receive a single dose of KAN-101 2. Part B - patients will receive three doses of either KAN-101 or placebo Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Celiac Disease
What is being tested?: KAN-101
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 13 sitesUnited States
Study dates: 21 Jan 2020to 8 Oct 2021
Phase: Phase 1
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 18 to 70 years inclusive
Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
Has followed a GFD for > 12 months immediately prior to study entry
Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
Capable of understanding and complying with protocol requirements
Patient understands and has signed the informed consent form

Who cannot join

Refractory celiac disease
Selective IgA deficiency
Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
Previous treatment with tolerance-inducing therapies for celiac disease
Known wheat allergy
Part B only: History of hyperacute or prolonged symptoms following gluten exposure

Show all 9Show fewer

Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
History of dermatitis herpetiformis
Pregnant or breastfeeding

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Innovative Medical Research of South Florida
Aventura, Florida, 33180
Parexel International- EPCU Baltimore
Baltimore, Maryland, 21225
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Aventiv Research
Columbus, Ohio, 43213
Tandem Clinical Research
Marrero, Louisiana, 70072
Celiac Disease Center at Columbia University
New York, New York, 10032
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Mayo Clinic
Rochester, Minnesota, 55905
GCP Research
St. Petersburg, Florida, 33705
Diablo Clinical Research
Walnut Creek, California, 94598
Advanced Clinical Research
West Jordan, Utah, 84088
West Michigan Clinical Research Center
Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)

A safety study of KAN-101 in patients with celiac disease. The study has two parts:

Part A - first in human study in which patients receive a single dose of KAN-101
Part B - patients will receive three doses of either KAN-101 or placebo

Read the detailed description

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).

An overview of the two parts and proposed dose groups is given below:

Part A (SAD): Patients will receive a single dose of KAN-101.
Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Conditions: Celiac Disease
Being tested: KAN-101, Placebo
Keywords: Phase 1, Double blind, Multicenter
Medical subject headings: Celiac Disease

What participants receive

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

KAN-101Drug
Intravenous (IV) infusion
PlaceboDrug
Intravenous (IV) infusion

Study groups in NCT04248855
Study group	Role	What they receive
SAD Cohort 1	Experimental	All enrolled patients will receive one dose of KAN-101 Dose A Receives: Drug: KAN-101
SAD Cohort 2	Experimental	All enrolled patients will receive one dose of KAN-101 Dose B Receives: Drug: KAN-101
SAD Cohort 3	Experimental	All enrolled patients will receive one dose of KAN-101 Dose C Receives: Drug: KAN-101
SAD Cohort 4	Experimental	All enrolled patients will receive one dose of KAN-101 Dose D Receives: Drug: KAN-101
MAD Cohort 5	Experimental	All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo Receives: Drug: KAN-101; Drug: Placebo
MAD Cohort 6	Experimental	All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo Receives: Drug: KAN-101; Drug: Placebo
MAD Cohort 7	Experimental	All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo Receives: Drug: KAN-101; Drug: Placebo

What is being measured

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

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Measured: Up to 28 Days

Secondary outcomes (2)

Cmax
Geometric mean of maximum drug concentration (Cmax)
Measured: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
AUC Last
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
Measured: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

Timeline

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

21 Jan 20208 Oct 2021

First posted30 Jan 2020
Study start21 Jan 2020
Primary completion8 Oct 2021
Study completion8 Oct 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Celiac DiseaseStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04248855
Sponsor's protocol ID: KAN-101-01
Status last verified: Aug 2024
First submitted: 28 Jan 2020
Last updated: 6 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
PubMed 37329900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)
ClinicalTrials.gov ID: NCT04248855
Acronym / sponsor ID: KAN-101-01
Conditions: Celiac Disease
Keywords: Phase 1, Double blind, Multicenter
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAIndustry (pharma, biotech, devices)
Study start: 21 Jan 2020 (actual)
Primary completion: 8 Oct 2021 (actual)
Study completion: 8 Oct 2021 (actual)
First posted: 30 Jan 2020 (actual)
Results: Posted 21 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A safety study of KAN-101 in patients with celiac disease. The study has two parts:

Part A - first in human study in which patients receive a single dose of KAN-101
Part B - patients will receive three doses of either KAN-101 or placebo

Detailed description

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).

An overview of the two parts and proposed dose groups is given below:

Part A (SAD): Patients will receive a single dose of KAN-101.
Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
SAD Cohort 1	Experimental	Drug: KAN-101All enrolled patients will receive one dose of KAN-101 Dose A
SAD Cohort 2	Experimental	Drug: KAN-101All enrolled patients will receive one dose of KAN-101 Dose B
SAD Cohort 3	Experimental	Drug: KAN-101All enrolled patients will receive one dose of KAN-101 Dose C
SAD Cohort 4	Experimental	Drug: KAN-101All enrolled patients will receive one dose of KAN-101 Dose D
MAD Cohort 5	Experimental	Drug: KAN-101, Drug: PlaceboAll randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
MAD Cohort 6	Experimental	Drug: KAN-101, Drug: PlaceboAll randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
MAD Cohort 7	Experimental	Drug: KAN-101, Drug: PlaceboAll randomized patients will receive 3 doses of either KAN-101 Dose C or placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Adults aged 18 to 70 years inclusive
Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
Has followed a GFD for > 12 months immediately prior to study entry
Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening

Key exclusion criteria (9 listed)

Refractory celiac disease
Selective IgA deficiency
Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
Previous treatment with tolerance-inducing therapies for celiac disease
Known wheat allergy

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
KAN-101Intravenous (IV) infusion	Drug	MAD Cohort 5, MAD Cohort 6, MAD Cohort 7, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4
PlaceboIntravenous (IV) infusion	Drug	MAD Cohort 5, MAD Cohort 6, MAD Cohort 7

Primary outcome

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 28 Days
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

2 secondary outcomes

Cmax
Time frame: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
AUC Last
Time frame: 0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7

Results and safety

Results posted to the registry on 21 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD 0.15mg/kg	4	4
SAD 0.3mg/kg	3	3
SAD 0.6mg/kg	3	3
SAD 1.2mg/kg	3	3
SAD 1.5mg/kg	1	1
MAD 0.15mg/kg	6	6
MAD 0.3mg/kg	7	6
MAD 0.6mg/kg	8	7
MAD Placebo	6	6

Primary outcome: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to 28 Days. Count of participants. Unit: Participants

Measure	SAD 0.15mg/kg n = 4	SAD 0.3mg/kg n = 3	SAD 0.6mg/kg n = 3	SAD 1.2mg/kg n = 3	SAD 1.5mg/kg n = 1	MAD 0.15mg/kg n = 6	MAD 0.3mg/kg n = 7	MAD 0.6mg/kg n = 8	MAD Placebo n = 6
TEAE	4	3	2	3	1	6	5	7	4
Grade 3 or higher TEAE	0	0	0	0	0	0	0	0	0
SAE	0	0	0	0	0	0	0	0	0
no TEAE	0	0	1	0	0	0	2	1	2

Population analysed: All patients who received any amount of study drug with treatment group based on the dose level received.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAD 0.15mg/kg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
SAD 0.3mg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
SAD 0.6mg/kg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
SAD 1.2mg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
SAD 1.5mg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
MAD 0.15mg/kg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
MAD 0.3mg/kg	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
MAD 0.6mg/kg	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
MAD Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37329900Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
Individual participant dataSharing planned: No

Related trials for Celiac Disease

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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.

Study Director study director

Kanyos Bio, Inc.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KAN-101 in people with Celiac Disease, run by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA at 13 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 8 inclusion and 9 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. 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?

Yes. Results are posted in the registry (first posted 21 Mar 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?

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 28 Days). 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 NCT04248855, which also lists 1 linked publication.

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 6 Aug 2024.