Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
52
Countries
5
Sites
18
celiac disease
Assess the ability of KAN-101 to attenuate gluten challenge (GC)-induced changes in duodenal histology as measured by changes in villus-height:crypt depth (Vh:Cd) ratio after a 2-week GC.
Key facts
- Sponsor
- Kanyos Bio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 30 Apr 2024 → 13 Jan 2025
- Decision date (initial)
- 2024-04-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Anokion SA
External identifiers
- EU CT number
- 2023-507240-37-00
- ClinicalTrials.gov
- NCT06001177
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
Assess the ability of KAN-101 to attenuate gluten challenge (GC)-induced changes in duodenal histology as measured by changes in villus-height:crypt depth (Vh:Cd) ratio after a 2-week GC.
Secondary objectives 4
- Examine the impact of KAN-101 on biomarker response (interleukin-2 [IL-2]) in peripheral blood following GC.
- Determine the effects of KAN-101 on histologic features (intraepithelial lymphocytes [IELs] density) in duodenum biopsies following 2-week GC.
- Assess the safety and tolerability of KAN-101 in participants with CeD.
- Assess the pharmacokinetics (PK) of multiple doses of KAN-101 in participants with CeD.
Conditions and MedDRA coding
celiac disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007864 | Celiac disease | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Adults aged 18 to 70 years inclusive.
- Previously documented diagnosis of CeD based on positive serology (eg, tissue transglutaminase IgA antibody and/or DGP IgG) AND intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy.
- HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes).
- Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening.
- Have followed a gluten-free diet for ≥12 months immediately prior to study entry (self-reported).
- Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher.
Exclusion criteria 10
- Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or symptoms with substantial villous atrophy (eg, documented Marsh score 3c in source data) despite strict adherence to a GFD for at least 12 months in absence of other disorders.
- Selective IgA deficiency.
- Positive for HLA-DQ8 genotype (DQA1*03, DQB1*0302) even if DQ2.5 is also present.
- Known wheat allergy.
- Diagnosis of type-I diabetes.
- History of dermatitis herpetiformis.
- Pregnant or breastfeeding.
- Known history of severe hypersensitivity reactions or anaphylaxis to gluten.
- Active gastrointestinal disease other than CeD (eg, inflammatory bowel disease, any forms of colitis except well-controlled microscopic colitis, uncontrolled IBS, peptic ulcer disease, eosinophilic esophagitis, and active GI infections).
- Previous treatment with tolerance-inducing therapies for CeD.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes from baseline in Vh:Cd ratio as assessed by esophagogastroduodenoscopy (EGD) with biopsy after 2-week GC (at Day 29).
Secondary endpoints 4
- IL-2 change from Day 15 (first day of GC) pre GC to Day 15 post GC.
- Changes from baseline in IEL density in duodenum biopsy after 2-week GC (at Day 29).
- •Incidence and severity of treatment emergent AEs as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (or higher). •Incidence and titer of KAN-101 anti-drug antibodies (ADA).
- Plasma concentration of KAN-101, and associated KAN-101 parameters: AUCinf, AUClast, Cmax, Tmax and t½.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10815846 · Product
- Active substance
- KAN-101
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 0.6 mg/kg milligram(s)/kilogram
- Max total dose
- 0.6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ANOKION SA
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 0.6 mg/kg milligram(s)/kilogram
- Max total dose
- 0.6 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kanyos Bio Inc.
- Sponsor organisation
- Kanyos Bio Inc.
- Address
- 50 Hampshire Street Ste 402
- City
- Cambridge
- Postcode
- 02139-1893
- Country
- United States
Scientific contact point
- Organisation
- Kanyos Bio Inc.
- Contact name
- Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)
Public contact point
- Organisation
- Kanyos Bio Inc.
- Contact name
- Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA)
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Masy Systems Inc. ORG-100039687
|
Pepperell, United States | Other |
| Rules Based Medicine Inc. ORG-100043610
|
Austin, United States | Other, Laboratory analysis |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
Locations
5 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 9 | 3 |
| Germany | Ended | 1 | 1 |
| Ireland | Ended | 6 | 6 |
| Netherlands | Ended | 1 | 1 |
| Poland | Ended | 9 | 7 |
| Rest of world
United States, Israel, Canada
|
— | 26 | — |
Investigational sites
Tampere University Hospital
Tays Research Services, Elamanaukio 2, 33520, Tampere
Clinical Research Services Turku CRST Oy
Clinical Research Services Turku - CRST Oy, Joukahaisenkatu 2 B, 20520, Turku
CRST Helsinki Oy
CRST Helsinki Oy, Energiakatu 4, 00180, Helsinki
Our Lady Of Lourdes Hospital
Gastroenterology, Windmill Road, A92 VW28, Drogheda
St Vincent's University Hospital
Gastroenterology, Nutley Lane Donnybrook, Elm Park, Dublin 4
Regional Hospital Mullingar
Gastroenterology, Longford Road, N91 NA43, Mullingar
University Hospital Galway
Gastroenterology, Newcastle Road, H91 YR71, Galway
Connolly Hospital
Gastroenterology, Mill Road, D15 X40D, Dublin 15
Beaumont Hospital
Gastroenterology, Beaumont Road, Beaumont, Dublin 9
Albert Schweitzer Ziekenhuis
Gastroenterology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Gastromed Sp. z o.o.
Gastromed, Ul. Grudziadzka 11/13-14, 87-100, Torun
Melita Medical Sp. z o.o.
Gastroenterology, Ul. Gen. Romualda Traugutta 1/7, 50-449, Wroclaw
Mz Badania Slowik Zymla Sp. j.
MZ Badania Slowik Zymla, Ul. Ks. Alojzego Kozielka 8, 44-190, Knurow
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Gastroenterology, U2 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
WIP Warsaw IBD Point Profesor Kierkuś
Gastroenterology Dpt, Bobrowiecka 9, 00-728, Warszawa
Sonomed Sp. z o.o.
Gastroenterolgy, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Centrum Medyczne Med-Gastr Sp. z o.o.
Gastroenterology, Ul. Mokra 4, 91-034, Lodz
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-05-30 | 2024-12-19 | 2024-08-07 | 2024-11-12 | |
| Germany | 2024-04-30 | 2024-12-12 | 2024-05-22 | 2024-11-12 | |
| Ireland | 2024-09-12 | 2024-12-03 | 2024-10-03 | 2024-11-12 | |
| Netherlands | 2024-06-11 | 2024-12-23 | 2024-07-09 | 2024-11-12 | |
| Poland | 2024-05-17 | 2024-12-20 | 2024-07-24 | 2024-11-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-72577
- Sponsor became aware
- 2025-02-24
- Date of breach
- 2024-05-22
- Submission date
- 2025-04-16
- Member states concerned
- Finland, Germany, Ireland, Netherlands, Poland
- Categories
- Protocol
- Areas impacted
- Subject safety
- Benefit-risk balance changed
- No
- Description
- Three improperly randomized patients in the two clinical studies due to incorrect reporting of a genetic test result.
- Sponsor actions
- 1. Requested vendor to open quality events and review results of the impacted test across the studies – vendor completed 24 Feb 2025 for QE 1 and 24 Mar 2025 for QE2 .
2. Notifications to affected sites and ethics committees to enable appropriate actions to be taken with patients (13 Feb 2025 for KAN-101-03) and the data safety monitoring board (DSMB, w/c 03 Mar 2025).
3. Vendor is revising internal processes (completion 17 Oct 2024) and implementing test-specific training of staff (completion 18 Apr 2025) before any manual reporting may be done.
4. Pfizer’s Regulatory Quality Assurance group will plan to audit Labcorp within the next 12 months.
| Organisation | City | Country | Type |
|---|---|---|---|
| Labcorp Central Laboratory Services S.a.r.l. | Meyrin | Switzerland | Analytical and Clinical laboratory |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results_2023-507240-37-00_KAN-101-03_Z0021001_EN SUM-98601
|
2025-09-19T19:05:50 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson Summary of Results_2023-507240-37-00_KAN-101-03_Z0021001_EN | 2025-09-19T19:06:45 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Sum of Results_2023-507240-37-00_KAN-101-03_Z0021001_EN | 1.0 |
| Summary of results (for publication) | Sum of Results_2023-507240-37-00_KAN-101-03_Z0021001_EN | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-27 | Finland | Acceptable 2024-04-02
|
2024-04-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-05 | Finland | Acceptable | 2024-04-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-27 | Finland | Acceptable | 2024-05-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-06 | Acceptable | 2024-07-15 |