SAFEGUARD (SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes) Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sab Biotherapeutics Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

22 Apr 2026 → ongoing

Decision date (initial)

2026-02-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-521560-36-00

WHO UTN

U1111-1320-2651

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Pharmacokinetic, Therapy, Safety

1) To learn about the safety and tolerability of two study treatment regimens in people recently diagnosed with Stage 3 type 1 diabetes.
2) To find out whether the study treatment can help slow the decline of insulin‑producing cells in the pancreas over the course of the study.

Conditions and MedDRA coding

Type 1 Diabetes

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Medicines And Healthcare Products Regulatory Agency, Federal Agency For Medicines And Health Products

EMA paediatric investigation plan (PIP)

EMEA-000000-PIP00-00

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants must be up to 40 years old and recently diagnosed with Stage 3 type 1 diabetes
2. Participants must be up to date with vaccines required by local or national health authorities
3. If female, participants must meet conditions that prevent pregnancy during the study (for example, not having started menstruation, being post‑menopausal, having had certain surgeries, or using reliable birth control)
4. Participants must have a positive test for at least one antibody linked to type 1 diabetes
5. Participants must agree not to take part in other experimental treatments during the study.

Exclusion criteria 5

1. Participants cannot have a known allergy or severe reaction to similar medicines or any ingredient in the study treatment
2. Participants cannot have taken part in another clinical trial within a set period before joining this study
3. Participants cannot have another autoimmune disease that requires immune system affecting treatment (except stable thyroid or celiac disease)
4. Participants cannot have serious health problems affecting the heart, liver, kidneys, or immune system, or have uncontrolled diabetes complications
5. Participants cannot have certain infections such as HIV, hepatitis B, or hepatitis C

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Recording and reviewing any health problems or side effects that occur during the study
2. Checking measures of pancreas function related to insulin production

Secondary endpoints 1

1. Monitoring blood sugar control, including information from continuous glucose monitoring devices

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sab Biotherapeutics Inc.

Sponsor organisation

Sab Biotherapeutics Inc.

Address

2100 East 54th Street North

City

Sioux Falls

Postcode

57104-5509

Country

United States

Scientific contact point

Organisation

Sab Biotherapeutics Inc.

Contact name

Senior Vice President of Regulatory Affairs / Quality

Public contact point

Organisation

Sab Biotherapeutics Inc.

Contact name

Senior Vice President of Regulatory Affairs / Quality

Third parties 9

Locations

11 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 280 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications