MK-6194 / Merck (MSD) - LARVOL DELTA

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006) (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jul 2028 ➔ Mar 2028 | Trial primary completion date: Apr 2027 ➔ Nov 2026

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Safety, pharmacokinetics, and pharmacodynamics of MK-6194, an IL-2 mutein designed to selectively activate regulatory T cells: single ascending dose and multiple ascending dose trial data. (PubMed, Immunohorizons) - "Minimal impact was observed on other lymphocytes including total T lymphocyte and natural killer cell counts. These findings support the further development of MK-6194 as a potential treatment for autoimmune disorders."

Clinical • Journal • PK/PD data • Dermatology • Eosinophilia • Immunology • IL2

A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014) (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006) (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jul 2027 ➔ Jul 2028 | Trial primary completion date: Jan 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013) (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

Design of a phase 2a, double-blind, placebo-controlled, global trial of MK-6194, a modified form of IL-2, in participants with non-segmental vitiligo. (EADV 2024) - P2 | "This phase 2a trial will outline the efficacy, safety, and tolerability of MK-6194 compared with placebo in patients with non-segmental vitiligo."

Clinical • P2a data • Dermatology • Immunology • Vitiligo • IL2

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (clinicaltrials.gov) - P2 | N=165 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Vitiligo

FIRST-IN-HUMAN SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS DATA WITH MK-6194, A MODIFIED FORM OF INTERLEUKIN-2, DESIGNED TO SELECTIVELY ACTIVATE REGULATORY T-CELLS – SINGLE ASCENDING DOSE AND MULTIPLE ASCENDING DOSE TRIALS (EULAR 2024) - "MK-6194 was generally well-tolerated up to a dose of 10 mg administered as a single SC dose and up to 5 mg administered SC Q2W or Q4W in healthy participants. The PK of MK-6194 was linear and dose-proportional, and observed Treg expansion was dose dependent without attenuation after repeat dosing. These results support further development of MK-6194 for the treatment of autoimmune disorders."

Clinical • P1 data • PK/PD data • Dermatology • Eosinophilia • Immunology • Inflammation • FOXP3 • IL2

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (clinicaltrials.gov) - P2 | N=165 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2026 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Jun 2025

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

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008) (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1 | N=57 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | N=30 ➔ 57

Enrollment change • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006) (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008) (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (clinicaltrials.gov) - P2 | N=165 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P2

Enrollment open • Phase classification • Dermatology • Immunology • Vitiligo

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

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

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ May 2024

Enrollment closed • Trial completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P1b ➔ P1

Phase classification • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (clinicaltrials.gov) - P2a | N=165 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2a trial • Dermatology • Immunology • Vitiligo

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting

Enrollment open • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1b | N=30 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2023 ➔ Mar 2024

Enrollment closed • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Mar 2024 ➔ Dec 2023

Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2024 ➔ Nov 2024 | Trial primary completion date: Mar 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008) (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008) (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology