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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000595314
Ethics application status
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Approved
Date submitted
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27/03/2026
Date registered
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12/05/2026
Date last updated
Help: Date last updated
12/05/2026
Date data sharing statement initially provided
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12/05/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
GIM-407 Phase 2a Pilot Study in Adults with Coeliac Disease
Scientific title
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Trial
Evaluating the Safety, Tolerability, and Efficacy of GIM407 in Adults With
Coeliac Disease
Additional trial identifiers [1] 315995 0
GIM407-CT02
Universal Trial Number (UTN)
Trial acronym
Related trial records
NCT06536101 was the Phase 1 SAD/MAD study for this compound, entitled "A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants". 

Health condition
Health condition(s) studied:
Coeliac Disease 339820 0
Condition category
Condition code
Inflammatory and Immune System 336065 336065 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a randomized, double-blind, placebo-controlled Phase 2a trial evaluating the safety, tolerability, immune response, and preliminary efficacy of GIM-407 in adults with confirmed coeliac disease by documented duodenal villous atrophy. All participants will receive a standardized daily gluten challenge while taking either GIM-407 or placebo for 6 weeks.

A total of approximately 20 participants are planned to be randomized 3:2 into two cohorts:
Cohort 1: GIM-407, 120 mg twice daily, plus gluten challenge (n = 12)
Cohort 2: Matching placebo twice daily, plus gluten challenge (n = 8)

To enable assessment of treatment effect both in the absence and presence of gluten antigen exposure, participants will begin study treatment (GIM-407 or placebo) in the morning of Day 1 (capsules to be taken with meals), with gluten challenge commencing on Day 4. Treatment and the daily gluten challenge will finish on Day 42. Participants will receive the investigational product (GIM-407 capsules or placebo capsules) in the morning and evening, with the morning dose followed by the gluten challenge. Gluten challenge will follow a titration schedule starting with 1 g on Day 4, 2 g on Day 5, and 3 g daily from Day 6 through Day 42.

Adherence will be monitored using a subject diary (date/time of each gluten and IP ingestion), weekly in-clinic or telehealth visits to check compliance, regular staff reminders with documentation of re-education, comprehensive dispensation records, and tracking of used/unused gluten packaging returned to site.
Intervention code [1] 332604 0
Treatment: Drugs
Description of the comparator or control
Cohort 2 will receive matching placebo twice daily, plus gluten challenge (n = 8). The placebo capsule contains soluplus, croscarmellose sodium, and microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 343606 0
To evaluate the safety and tolerability of twice daily oral administration of GIM-407 (120 mg) as a composite primary outcome.
Timepoint [1] 343606 0
AEs will be assessed Day 1 to end of study (EOS) (per trial schema, Week 10 final EOS visit). Lab tests, urinalysis, PE & VS at Weeks 1,2,4,6 and EOS ECG at Day 1 (pre, 1h, 2h post), Day 4, Day 28, Day 42, EOS. CDSD - daily Day 1 to Day 42. Participant Self-reporting - throughout study
Primary outcome [2] 343607 0
To assess the impact of twice daily oral administration of GIM-407 (120mg) on intestinal villous atrophy,
Timepoint [2] 343607 0
Screening (up to 1 week before dosing) and Week 6-7 post first dose
Secondary outcome [1] 454861 0
To characterize the pharmacokinetics (PK) of GIM-407 following twice daily oral dosing for 6 weeks in adults with coeliac disease (CeD).
Timepoint [1] 454861 0
Pharmacokinetics Schedule: Day 1 - Pre-dose; Day 7 - 0 min (pre-dose), 15 min, 30 min, 1h, 1.5h, 2h; Day 28 -0 min (pre-dose), 15 min, 30 min, 1h, 1.5h, 2h, 4h; Day 42 - 0 min (pre-dose), 15 min, 30 min, 1h, 1.5h, 2h, 4h; Day 72 - 1 sample during visit
Secondary outcome [2] 454862 0
Evaluate the pharmacodynamic activity of GIM-407 as a composite outcome by assessing: a. Changes in Treg frequency in blood and, where possible, gut/peripheral lymphoid tissue; b. Changes in exploratory immune/inflammatory biomarkers (e.g. IL-10) relevant to coeliac disease
Timepoint [2] 454862 0
Assessed at Screening, Day 1, Day 4, Day 7, Day 42, and EOS
Secondary outcome [3] 460535 0
To investigate the effect of GIM-407 on gluten-induced gut mucosal injury.
Timepoint [3] 460535 0
Assessed at Screening (up to 1 week before dosing) and Week 6-7
Secondary outcome [4] 460536 0
To assess changes in patient-reported CeD symptoms in participants treated with GIM-407 vs placebo
Timepoint [4] 460536 0
Diary entries from Day 1 to Day 42

Eligibility
Key inclusion criteria
• Have a body mass index (BMI) of 18 to 32 kg/m2 (inclusive).

• Participants who have adequate hematologic and biological function confirmed by the following lab values at Screening:
a. Hemoglobin greater than or equal to 10g/dL
b. Platelet Count greater than or equal to 125/L
c. Total White Blood Cell Count greater than 3500 cells/mm3
d. AST and ALT less than 2 x upper limit of normal
e. eGFR greater than 60ml/min/1.73 m2 based on the Cockcroft-Gault equation

• Participants assigned female at birth are eligible to participate if they are not pregnant, not breastfeeding, and at least ONE of the following conditions applies:
a. Are a participant of nonchildbearing potential or are a participant of childbearing potential (POCBP) and agree to use a highly effective method of contraception consistently and correctly and have their partner use a barrier method starting from time of Screening until at least 30 days after the last dose of IP.
b. Participants assigned male at birth who are sexually active with a female partner of childbearing potential are eligible to participate if they agree to use a condom and have their partner use a highly effective method of contraception from Day 1 until at least 30 days after the last dose of IP.
c. Participants must refrain from donating eggs (ova, oocytes) or sperm from Day 1 until at least 90 days after receiving the last dose of the IP.

• Documented duodenal villous atrophy in the past when coeliac disease was diagnosed and report adhering to a gluten-free diet for at least 12 months.

• A positive Novoleukin-C test

• Have a normal IgA anti-tissue transglutaminase or anti-DPG

• Are willing to undergo 2 upper gastrointestinal endoscopies required in this study

• Willingness to consume a defined amount of gluten for 6 weeks

• Are available for weekly telehealth or on-site consultations for the 6-week treatment period
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Has an acute or chronic medical condition that, in the opinion of the Investigator, would render the study procedures unsafe for the participant or may confound the results of the study.

• History or presence of any disease that affects IP absorption, distribution, metabolism, or excretion as judged by the Investigator (eg, gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, cholecystectomy, etc).
a) EXCEPTION: Previous/history of appendectomy is not exclusionary.

• Signs of any current active infections, including localized infections, or any recent history of active infections, cough, or fever within 1 week prior to IP administration or any history of recurrent or chronic infections.

• Participant has a diagnosis of Refractory Coeliac Disease

• Participant has a diagnosis or suspicion of other conditions that may potentially be mis-diagnosed as CeD

• Participant has a history of findings of or screening laboratory findings indicative of selective IgA deficiency.

• Presence of poorly controlled insulin treated diabetes (T1D or T2D) or clinically significant disease that, in the opinion of the investigator, may put the participant at risk in the study, or influence the results or the participant’s ability to participate in the study.

• Known history of significant multiple and/or severe allergies (eg, food, drug, or latex allergy), wheat allergy, or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.

• History of or current invasive malignancy including hematological malignancies. Participants with a history of basal cell or squamous cell carcinoma or other carcinomas in situ that has been treated with no evidence of recurrence within 1 year prior to Screening will be allowed for inclusion, as judged by the Investigator.

• Family history of sudden death or of congenital prolongation of the QT interval corrected for heart rate (QTc) or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.

• Tested positive during the urine drug screen at Screening.
a) NOTE: One repeat screen is allowed at the discretion of the Investigator.

• Medically uncontrolled hypertension (e.g. Systolic BP >180 or Diastolic BP>110), NYHA Class III or IV cardiac disease, myocardial infarction within prior 6 months, unstable angina pectoris, unstable arrhythmias, or any cardiovascular abnormalities in the investigator’s opinion which would make the subject unsuitable for study participation.

• QTcF >450 msec for male participants and >470 msec for female participants per ECG at Screening or on Day–1.

• History of significant drug or alcohol abuse during the year prior to study screening as obtained by medical record and/or subject report.

• Donated blood (including blood products) or experienced significant loss of blood =450 mL within 30 days prior to Screening, or donated plasma within 7 days of Screening.

• Use of any enzyme-inducing, or enzyme-inhibiting drugs (eg. strong CYP450 inducers or inhibitors), biologic drugs, or any drug known to have a well-defined potential for hepatotoxicity (eg, isoniazide, nimesulide, ketoconazole) within 3 months or 5 half-lives of the drug (whichever is longer) prior to first dose of the IP, or their planned use during the study period.

• Use of systemic immune suppressants, including systemic steroids ( >10mg prednisone equivalent) within 3 months or 5 half-lives, whichever is longer prior to first dose of the IP, or their planned use during the study period.

• Receipt of an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the IP.

• Have received any live vaccines (bacterial or viral) within 30 days prior to the first dose of IP or intend to receive a live vaccine during the study period. EXCEPTIONS: Vaccines allowed by the protocol include inactivated flu and COVID-19 vaccines in all participants. The recommended time intervals for administration of these vaccines are at least 7 days before the first dose of IP or 7 days after the last dose of IP.

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug, vaccine, or invasive medical device).

• Pregnant or breastfeeding female participant or who is planning to become pregnant or planning to discontinue contraceptive precautions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via EDC system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed on Day 1 via the electronic data capture (EDC) system. A computer-generated randomization schedule will be created by an unblinded statistician prior to study start and uploaded into the EDC. Randomization to GIM-407 or placebo will be performed in a 3:2 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 320597 0
Commercial sector/Industry
Name [1] 320597 0
Georgiamune Australia Pty Ltd
Country [1] 320597 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Georgiamune Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 323229 0
None
Name [1] 323229 0
Address [1] 323229 0
Country [1] 323229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319140 0
Bellberry Human Research Ethics Committee J
Ethics committee address [1] 319140 0
Ethics committee country [1] 319140 0
Australia
Date submitted for ethics approval [1] 319140 0
24/09/2025
Approval date [1] 319140 0
04/11/2025
Ethics approval number [1] 319140 0
2025-09-1569

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146378 0
Dr Robert Anderson
Address 146378 0
JM Clinical Pty Ltd, 87 Ipswich Road Woolloongabba QLD 4102
Country 146378 0
Australia
Phone 146378 0
+61 432 491 089
Fax 146378 0
Email 146378 0
[email protected]
Contact person for public queries
Name 146379 0
Noha Alghamdi
Address 146379 0
Molecule2Market Level 3, 55 Collins Street Melbourne VIC 3000
Country 146379 0
Australia
Phone 146379 0
+61 406 621 961
Fax 146379 0
Email 146379 0
[email protected]
Contact person for scientific queries
Name 146380 0
Dr Mark Sostek
Address 146380 0
Georgiamune, Inc. 942 Clopper Rd, Gaithersburg, MD 20878, United States
Country 146380 0
United States of America
Phone 146380 0
+1 215 816 8318
Fax 146380 0
Email 146380 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.