FB-102 / Forte Biosci - LARVOL DELTA

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Aug 2026 ➔ Mar 2027

Enrollment open • Trial primary completion date • Alopecia • Dermatology • Immunology

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Forte Biosciences, Inc. | N=16 ➔ 64 | Trial completion date: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Dermatology • Immunology • Vitiligo

Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Forte Biosciences, Inc. | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Celiac Disease • Immunology

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after multiple dose administration in participants with celiac disease. (ANZCTR) - P1 | N=32 | Active, not recruiting | Sponsor: Forte Biosciences, Australia Pty Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology • Inflammation

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P1 trial • Alopecia • Dermatology • Immunology

Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FB102 IN ADULT WITH CELIAC DISEASE (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P2 trial • Celiac Disease • Immunology

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Vitiligo

A Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-segmental Vitiligo (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P1 trial • Dermatology • Immunology • Vitiligo

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants (ANZCTR) - P1 | N=80 | Completed | Sponsor: Forte Biosciences Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Immunology • Inflammation

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after multiple dose administration in participants with celiac disease. (ANZCTR) - P1 | N=32 | Not yet recruiting | Sponsor: Forte Biosciences, Australia Pty Ltd

New P1 trial • Celiac Disease • Immunology • Inflammation

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants (ANZCTR) - P1 | N=80 | Recruiting | Sponsor: Forte Biosciences Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023

Enrollment open • Trial initiation date • Immunology • Inflammation

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants (ANZCTR) - P1 | N=80 | Not yet recruiting | Sponsor: Forte Biosciences Australia Pty Ltd

New P1 trial • Immunology • Inflammation

Forte Biosciences, Inc. Announces $25 Million Financing and R&D Update for FB-102 (Businesswire) - "Forte Biosciences...today announced key R&D updates for FB-102 and the closing of financing to support the advancement of FB-102....We plan to advance FB-102 into the clinic in 2024....In a validated preclinical model of aggressive acute GvHD using transplanted human donor PBMCs, FB-102 reported 90% survival versus 0% survival on vehicle control and compared to 60% survival on ruxolitinib. In combination with ruxolitinib, the only FDA-approved treatment for acute GvHD, FB-102 reported 90% survival compared to 0% survival on vehicle control and 30% survival for ruxolitinib alone with extended duration of dosing compared to the single agent study."

Financing • New trial • Preclinical • Acute Graft versus Host Disease • Graft versus Host Disease