FB-102
/ argenx
- LARVOL DELTA
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August 20, 2026
A Study Testing the Safety and Effects of FB102 in Healthy Volunteers
(clinicaltrials.gov)
- P1 | N=48 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting
Enrollment open
August 27, 2026
argenx Completes Acquisition of Forte Biosciences, Inc.
(GlobeNewswire)
- "The acquisition expands argenx’s portfolio of differentiated immunology medicines, adding FB102, a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease and potential to address multiple autoimmune diseases. The acquisition reflects argenx’s disciplined approach to identifying and advancing breakthrough science for patients with the potential to redefine standards of care in diseases that have lacked meaningful innovation for decades."
M&A • Celiac Disease • Immunology • Vitiligo
July 27, 2026
Argenx…announced that the companies have entered into a definitive agreement under which argenx will acquire Forte Biosciences for $77 per share in cash, representing a total equity value of approximately $2.2 billion.
(Businesswire)
- "FB102, Forte Biosciences’ lead program, expands argenx’s portfolio of differentiated immunology medicines, adding a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease and potential to address multiple autoimmune diseases."
M&A • Celiac Disease • Vitiligo
June 04, 2026
A Study Testing the Safety and Effects of FB102 in Healthy Volunteers
(clinicaltrials.gov)
- P1 | N=56 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.
New P1 trial
November 21, 2025
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
November 21, 2025
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
November 19, 2025
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
November 01, 2025
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
October 04, 2025
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
August 23, 2025
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
May 21, 2025
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
April 25, 2025
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
April 02, 2025
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
February 14, 2025
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
August 16, 2024
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
July 12, 2024
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
November 24, 2023
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
August 01, 2023
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
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