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    DRUG CLASS:

    OX40 ligand inhibitor

    Related drugs:
    15d
    RIVER-AD: Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (clinicaltrials.gov)
    P2/3, N=1663, Enrolling by invitation, Sanofi | Recruiting --> Enrolling by invitation
    Enrollment status
    1m
    ESTUARY: A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov)
    P3, N=1541, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    1m
    An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov)
    P1, N=80, Recruiting, Apogee Therapeutics, Inc. | N=50 --> 80
    Enrollment change
    |
    Dupixent (dupilumab)
    1m
    A First-in-human Study of APG990 in Healthy Participants (ACTRN12624000775516)
    P1, N=40, Completed, Apogee Therapeutics, Inc. | Recruiting --> Completed
    Trial completion
    2ms
    A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=212, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    2ms
    SHORE: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (clinicaltrials.gov)
    P3, N=643, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion
    2ms
    BRIGHTEN: Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=188, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open
    2ms
    COAST 1: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov)
    P3, N=601, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion
    2ms
    The OX40-OX40L Co-stimulatory pathway in dermatology: emerging frontiers for therapeutic approaches. (PubMed, Inflamm Res)
    The complex interplay between mast cells expressing OX40L and T cells expressing OX40, which in some contexts can inhibit regulatory T cell (Treg) function and promote Th17 differentiation, underscores the therapeutic potential of either antagonizing or agonizing this co-stimulatory pathway. In this review, we discuss selected dermatological diseases in which the OX40/OX40L axis appears relevant to their immunopathogenesis and may serve as a potential therapeutic target.
    Review • Journal
    |
    CD8 (cluster of differentiation 8) • TNFSF4 (TNF Superfamily Member 4)
    3ms
    Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=90, Terminated, Sanofi | Trial completion date: Jan 2027 --> Oct 2025 | Active, not recruiting --> Terminated; Sponsor decision; the decision is not related to any safety concern
    Trial completion date • Trial termination
    3ms
    ESTUARY: A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov)
    P3, N=1500, Recruiting, Sanofi | Trial primary completion date: Oct 2026 --> Jun 2026
    Trial primary completion date
    3ms
    ESTUARY: A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov)
    P3, N=1500, Recruiting, Sanofi | N=961 --> 1500 | Trial primary completion date: Jun 2026 --> Oct 2026
    Enrollment change • Trial primary completion date