TEV-53408 for Celiac disease

Inclusion criteria

• {"criterion_text":"- a. Male or female (assigned sex at birth) ≥18 to <65 years of age, inclusive, at the time of signing the informed consent.\n- b. Diagnosis of celiac disease at least 12 months prior to screening (documentation required at screening): − Participant has documentation of EGD confirming celiac disease and positive antibodies, or − If the participant is <30 years of age and a biopsy was not performed at the time of the celiac diagnosis, the participant had met the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) criteria for diagnosis.\n- c. On a gluten-free diet for at least 12 months prior to screening, as determined by the investigator through participant interview.\n- d. tTg IgA <2 U/mL at screening.\n- e. Minimal enteropathy as determined by Vh:Cd ≥2.0 on a duodenal biopsy (EGD) performed during screening period.\n- f. No moderate or severe gastrointestinal symptoms attributable to celiac disease at Screening (visit 1) based on the Symptom Screening Tool.\n- g. Positive at screening for HLA DQ2 or HLA DQ8.\n- h. Body mass index >18.5 to 40 kg/m2 (inclusive).\n- i. Women of non-childbearing potential should be: − congenitally or surgically sterile (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) as assessed by a physician, or − 1-year postmenopausal (no menses for at least 12 months without an alternative medical cause, plus either a concentration of follicle-stimulating hormone [FSH] within the postmenopausal range [an increased concentration of FSH of more than 35 IU/L] in women not using hormonal contraception/hormonal replacement therapy [HRT], or medical documentation of menopause for women on HRT).\n- j. Women of childbearing potential (WOCBP) must have a negative β-human chorionic gonadotropin (HCG) test result and practice a highly effective method of birth control prior to IMP administration and for the duration of trial participation, or for 5 half-lives of TEV-53408 (28 weeks) after IMP administration, whichever is longer.\n- k. Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period.\n- l. Male participants (including vasectomized) with WOCBP partners (whether pregnant or not) must use condoms and also agree not to donate sperm after IMP administration and for the duration of trial participation, or for 5 half-lives of TEV-53408 (28 weeks) after IMP administration, whichever is longer.\n- m. Participants should be capable of giving signed informed consent, and willing and able to comply with trial procedures, including duodenal biopsy both during screening and at week 8, maintaining the gluten challenge, and other restrictions."}

Exclusion criteria

• {"criterion_text":"- a. A diagnosis or suspicion of refractory celiac disease.\n- j. The participant has a history of chronic alcohol or substance abuse disorder within the previous 2 years.\n- k. The participant has an active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening.\n- l. Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to IMP administration. Live vaccines include, but are not limited to, measles, mumps, rubella (MMR combined vaccine), rotavirus, smallpox, chickenpox, yellow fever, and oral polio vaccine.\n- m. An active infection with EBV or CMV, with a confirmed EBV or CMV PCR-based viral DNA level of ≥10000 IU/mL obtained at screening. Note: “Confirmed” is defined by a repeat positive test within 7 days of the reporting of the initial finding.\n- n. A clinically active infection of HPV, VZV, or HSV 1/2 at screening or baseline.\n- o. Active tuberculosis (TB) (as determined by the QuantiFERON® TB Gold Test) or history of untreated latent or active TB. Note: If the QuantiFERON ® TB Gold Test is indeterminate, a second test should be performed through the central laboratory or local. If the second test is positive, the participant is considered to be positive. If the second test is negative, the participant is considered to be negative.\n- p. Positive viral serology at screening: − Hepatitis B: hepatitis B surface antigen (HBsAg) positive or detected sensitivity on the HBV-DNA PCR qualitative test for hepatitis B core total antibody (HBcAb)/hepatitis B surface antibody (HBsAb) positive participants − Hepatitis C: HCV ribonucleic acid (RNA) detectable in any participant with positive anti-HCV antibody (HCVAb) − Human immunodeficiency virus (HIV) Types 1 or 2 Ab (confirmed positive serology test, according to 4th generation serology testing)\n- q. Participant has a history of opportunistic or serious infection that makes the participant an unsuitable candidate for the trial (if the infection is oral herpes simplex or palmoplantar warts, then the participant will be allowed).\n- b. History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional (either inpatient or outpatient) for management, dermatitis herpetiformis, or history of neurological symptoms including ataxia after gluten exposure.\n- c. Any other gastrointestinal disease or condition that may interfere with the assessment of celiac disease, such as irritable bowel syndrome, lactose intolerance, uncontrolled gastroesophageal reflux disease, ulcerative colitis, Crohn’s disease, or microscopic colitis. In addition, participants who have evidence on screening endoscopy of greater than Grade A esophagitis, eosinophilic esophagitis, or active peptic ulcer are excluded.\n- d. Current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma.\n- e. Pregnant or lactating woman, or plans to become pregnant during the trial; any man who is considering fathering a child or donating sperm during the trial.\n- f. The participant is currently participating in, or has participated in another trial of an IMP (or a medical device) within the previous 30 days or 5 half-lives of the IMP (whichever is longer).\n- g. The participant has previously been randomized within this trial or has participated previously in a trial with TEV-53408 or another anti–IL-15 therapy. In addition, participants who received any other immunotherapy for celiac disease within 2 years prior to screening are excluded.\n- h. Known hypersensitivity or idiosyncratic reaction to the IMP, its related compounds, or to any metabolites or any compound listed as being present in a trial formulation or other IMP; history of anaphylactic reactions to protein therapeutics or known hypersensitivity to any ingredients listed in the label of the daily gluten dose that is to be consumed during the gluten challenge in this trial.\n- i. Donated or received any blood or blood products (eg, WBCs, platelets) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to IMP administration, or donated plasma within 7 days before the screening visit or has planned donations during the trial. The minimum reference volume of whole blood lost or donated is 500 mL.\n- z. The participant is an employee of the sponsor or the site or a relative of an employee at the site conducting the trial.\n- aa. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n- bb. Legal or mental incapacitation, or inability to understand and comply with the requirements of the trial.\n- cc. Participants incapable of giving written informed consent.\n- k. The participant has an active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening.\n- l. Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to IMP administration. Live vaccines include, but are not limited to, measles, mumps, rubella (MMR combined vaccine), rotavirus, smallpox, chickenpox, yellow fever, and oral polio vaccine.\n- m. An active infection with EBV or CMV, with a confirmed EBV or CMV PCR-based viral DNA level of ≥10000 IU/mL obtained at screening. Note: “Confirmed” is defined by a repeat positive test within 7 days of the reporting of the initial finding.\n- n. A clinically active infection of HPV, VZV, or HSV 1/2 at screening or baseline.\n- o. Active tuberculosis (TB) (as determined by the QuantiFERON® TB Gold Test) or history of untreated latent or active TB. Note: If the QuantiFERON ® TB Gold Test is indeterminate, a second test should be performed through the central laboratory or local. If the second test is positive, the participant is considered to be positive. If the second test is negative, the participant is considered to be negative.\n- p. Positive viral serology at screening: − Hepatitis B: hepatitis B surface antigen (HBsAg) positive or detected sensitivity on the HBV-DNA PCR qualitative test for hepatitis B core total antibody (HBcAb)/hepatitis B surface antibody (HBsAb) positive participants − Hepatitis C: HCV ribonucleic acid (RNA) detectable in any participant with positive anti-HCV antibody (HCVAb) − Human immunodeficiency virus (HIV) Types 1 or 2 Ab (confirmed positive serology test, according to 4th generation serology testing)\n- q. Participant has a history of opportunistic or serious infection that makes the participant an unsuitable candidate for the trial (if the infection is oral herpes simplex or palmoplantar warts, then the participant will be allowed)."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in villous atrophy, as assessed by Vh:Cd, at week 8.\n- Incidence of treatment-emergent adverse events up to week 28.\n- Incidence of serious adverse events up to week 28.\n- Incidence of PDAESIs up to week 28.\n- Incidence of early discontinuations during the treatment period (up to week 28) due to an adverse event.","definition_or_measurement_approach":"- Assess Vh:Cd (villous height to crypt depth ratio) change from baseline at week 8 as measured on duodenal biopsy (EGD) specimens.\n- Treatment-emergent adverse events: incidence captured through safety reporting up to week 28.\n- Serious adverse events: incidence captured through SAE reporting up to week 28.\n- PDAESIs: incidence captured up to week 28 (as reported in trial safety monitoring).\n- Early discontinuations due to adverse events: recorded during the treatment period up to week 28."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in IEL density at week 8.\n- Change from baseline in a composite measure of VCIEL at week 8.","definition_or_measurement_approach":"- IEL density change from baseline at week 8 measured on duodenal biopsy tissue.\n- Composite VCIEL measure change from baseline at week 8 measured using the trial's specified composite histologic scoring on biopsy."}

Methods

• Recruitment arrangements document: K1_Recruit-ICF process_FP (document listed under recruitment arrangements for publication) — associated with Part II (Finland).
• Recruitment email: K2_Recruit email_TT_FP — indicates use of email outreach materials.
• Newsletter advertisement: K2_Newsletter adv_FP — indicates use of newsletter advertisement materials.
• Participant-facing materials: K2_Take part_FP and K2_Participating_FP — 'take part' and participating information documents for potential participants.
• Contact materials: K2_Contact us_FP and K2_Contact us2_FP — 'Contact us' materials (likely for enquiries/interest).
• Eligibility information: K2_Eligibility_FP — eligibility information provided to potential participants.

Finland

Earliest CTIS Part Ii Submission Date

07-03-2025

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

398

Number Of Sites

2

Number Of Participants

5

Primary sponsor

Full Name

Teva Branded Pharmaceutical Products R&D LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: 1,12,2,5,8; contact email CTISAuthorityCommunications-Pharma@iconplc.com; phone +35312912000

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,12,2,5,8 (as listed in CTIS record); contact email CTISAuthorityCommunications-Pharma@iconplc.com","organisation_type":"Pharmaceutical company"}