D-2570 / InventisBio - LARVOL DELTA

N/Z: A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Dermatology • Immunology • Psoriasis

Mass Balance Study of [14C] D-2570 (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral TYK2 Inhibitor D-2570 in Healthy Subjects: A First-in-Human Phase I Study. (PubMed, Clin Transl Sci) - "These results provide the rationale for dose selection in future clinical trials and support advancing D-2570 as a potential treatment option for autoimmune diseases mediated by tyrosine kinase 2. Trial Registration: Chinadrugtrials.org.cn (CTR20222168)."

Clinical • First-in-human • Journal • P1 data • PK/PD data • Immunology • IFNG • IL12A • IL18 • TYK2

A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis. (clinicaltrials.gov) - P3 | N=477 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P3 trial • Dermatology • Immunology • Psoriasis

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

D2570-204: A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=390 | Recruiting | Sponsor: InventisBio Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Healthy Volunteer Study (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial

Novel TYK2 inhibitor D-2570 in moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase 2 trial. (PubMed, J Am Acad Dermatol) - P2 | "D-2570 demonstrated a high efficacy with favorable safety profile in patients with moderate to severe plaque psoriasis."

Clinical • Journal • P2 data • Immunology • Psoriasis • IL17A • TYK2

Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=390 | Not yet recruiting | Sponsor: InventisBio Co., Ltd

New P3 trial • Dermatology • Immunology • Psoriasis

Yifang Biopharma D-2570 tablets start Phase III clinical trial for moderate to severe plaque psoriasis [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform show that a multicenter randomized, double - blind , placebo - controlled Phase III clinical study evaluating the efficacy and safety of D-2570 in the treatment of moderate to severe plaque psoriasis has been launched by Yifang Biotechnology (Shanghai) Co., Ltd. The clinical trial registration number is CTR20252503, and the first public information date is July 2, 2025...The main purpose of this trial is to evaluate whether different doses of D-2570 are better than placebo in the treatment of moderate to severe plaque psoriasis patients at week 16; secondary objectives include evaluating long-term treatment effects, safety, and population pharmacokinetic and pharmacodynamic characteristics....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 390 people."

Trial status • Psoriasis

D2570-202: A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Yifang Bio: D-2570 completed first patient dosing in Phase II clinical trial for ulcerative colitis [Google translation] (Eastmoney.com) - "Regarding the latest clinical progress of D-2570, the company stated that the Phase II clinical trial application for D-2570 for the indication of ulcerative colitis has been approved by the CDE, and the first patient in the trial was dosed in May 2025."

Trial status • Ulcerative Colitis

D2570-201: Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=161 | Completed | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Nov 2024

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

InventisBio Announces Positive Phase 2 Study Results for D-2570 (TYK2 Inhibitor) in Patients with Moderate to Severe Plaque Psoriasis (PRNewswire) - P2 | N=160 | NCT06278350 | Sponsor: InventisBio Co., Ltd | "The randomized, multicenter, double-blind, placebo-controlled study demonstrated that D-2570 achieved significant efficacy in improving skin clearance while maintaining a favorable safety profile....≥85% of patients treated with D-2570 in all three dose groups achieved PASI 75 (75% or greater improvement in the Psoriasis Area and Severity Index) by week 12, compared to 12.5% in placebo group. 50% of patients receiving the high dose of D-2570 achieved PASI 100 (complete skin clearance) by week 12, compared to 2.5% in placebo group. PASI 90 and sPGA 0/1 responses also significantly favored D-2570 over placebo, with 77.5% and 87.5%, respectively, in the high-dose group, versus 5.0% and 20%, respectively, in placebo group....The complete data from this Phase 2 trial will be presented at upcoming scientific conferences."

P2 data • Psoriasis

Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: InventisBio Co., Ltd

New P2 trial • Dermatology • Immunology • Psoriasis