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    DRUG CLASS:

    PDE4 inhibitor

    Related drugs:
    1d
    A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    2d
    MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia (clinicaltrials.gov)
    P2, N=40, Recruiting, MediciNova | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    7d
    The holistic management of peripheral spondyloarthritis: focus on articular involvement in patients with inflammatory bowel disease. (PubMed, Reumatismo)
    Early identification of pSpA is crucial in IBD patients to enable timely intervention, prevent structural damage, and minimize disability. A multidisciplinary, holistic approach addressing musculoskeletal and extra-musculoskeletal manifestations is key to optimal patient outcomes.
    Journal
    |
    IL23A (Interleukin 23 Subunit Alpha)
    11d
    Roflumilast and TMS Motor Plasticity (clinicaltrials.gov)
    P1, N=20, Recruiting, University of Calgary | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> Nov 2024
    Enrollment open • Trial initiation date
    |
    Daliresp (roflumilast)
    14d
    Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD) (clinicaltrials.gov)
    P1, N=12, Completed, Stalicla SA | Phase classification: P1b --> P1
    Phase classification
    15d
    Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH (clinicaltrials.gov)
    P2, N=55, Completed, Tanta University
    New P2 trial
    |
    Daliresp (roflumilast)
    24d
    Phase 1 Study Evaluating PALI-2108 in Healthy Volunteers and Ulcerative Colitis Patients. (clinicaltrials.gov)
    P1, N=90, Recruiting, Palisade Bio
    New P1 trial
    |
    CRP (C-reactive protein)
    25d
    RPL554-CO-303: Effect of Ensifentrine Treatment on CAT Score (clinicaltrials.gov)
    P3, N=20, Active, not recruiting, Verona Pharma plc | Recruiting --> Active, not recruiting
    Enrollment closed
    1m
    EBULO: A 20-Week Study Assessing the Efficacy of Apremilast in Patients With EB Simplex Generalized (clinicaltrials.gov)
    P2, N=20, Recruiting, Centre Hospitalier Universitaire de Nice | Not yet recruiting --> Recruiting | Trial completion date: Aug 2025 --> Dec 2025
    Enrollment open • Trial completion date
    1m
    EBULO: A 20-Week Study Assessing the Efficacy of Apremilast in Patients With EB Simplex Generalized (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Centre Hospitalier Universitaire de Nice | Trial completion date: Aug 2024 --> Aug 2025 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    1m
    Efficacy and Safety of Roflumilast Cream 0.3% in Subjects with Plaque Psoriasis: a Phase 3 Study (clinicaltrials.gov)
    P3, N=189, Not yet recruiting, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
    New P3 trial
    1m
    Allo-X: Exercise as an Immune Adjuvant for Allogeneic Cell Therapies (clinicaltrials.gov)
    P1, N=100, Recruiting, University of Arizona
    New P1 trial
    |
    Daliresp (roflumilast)
    1m
    A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food (clinicaltrials.gov)
    P1, N=15, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    2ms
    Efficacy and Safety of Roflumilast Cream in Subjects with Atopic Dermatitis: a Phase 3 Study (clinicaltrials.gov)
    P3, N=210, Not yet recruiting, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
    New P3 trial
    2ms
    A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Boehringer Ingelheim
    New P1 trial
    2ms
    Bioequivalence Test of Hemay005 Tablets (clinicaltrials.gov)
    P1, N=28, Not yet recruiting, Ganzhou Hemay Pharmaceutical Co., Ltd
    New P1 trial
    2ms
    Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Ganzhou Hemay Pharmaceutical Co., Ltd
    New P1 trial
    2ms
    TQC3721-II-03: A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov)
    P2, N=240, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    2ms
    Cyclic adenosine monophosphate critically modulates cardiac GLP-1 receptor's anti-inflammatory effects. (PubMed, Inflamm Res)
    cAMP, via activation of both PKA and Epac, is essential for GLP1R`s anti-inflammatory signaling in cardiac cells and that cAMP levels crucially regulate the anti-inflammatory efficacy of GLP1R agonists in the heart. Strategies that elevate cardiac cAMP levels, such as PDE4 inhibition, may potentiate the cardiovascular, including anti-inflammatory, benefits of GLP1R agonist drugs.
    Journal
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • MMP9 (Matrix metallopeptidase 9)
    |
    IL6 expression
    |
    Daliresp (roflumilast)
    2ms
    Efficacy and Safety of Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo Patients (clinicaltrials.gov)
    P4, N=30, Not yet recruiting, Dow University of Health Sciences
    New P4 trial • Combination therapy
    2ms
    A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis (clinicaltrials.gov)
    P2, N=180, Recruiting, Verona Pharma plc | Not yet recruiting --> Recruiting
    Enrollment open
    2ms
    Establishment of Precision Medicine and Individualized Standardized Treatment Pathway for Psoriasis in China Subtopic 2: Exploring the Efficacy, Safety Evaluation, and Individualized Protocol Exploration of Low dose Targeted IL-17 Axis Biological Agents Combined with Apremilast Tablets in the Treatment of Adult Moderate to Severe Psoriasis Vulgaris (ChiCTR2400087472)
    P=N/A, N=162, Not yet recruiting, Department of Dermatology, Huashan Hospital, Fudan University; Peking university first hospital
    New trial
    |
    IL17A (Interleukin 17A)
    2ms
    A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body (clinicaltrials.gov)
    P1, N=64, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    2ms
    A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body (clinicaltrials.gov)
    P1, N=64, Completed, Boehringer Ingelheim | Recruiting --> Completed
    Trial completion
    2ms
    Tuberculosis reactivation following apremilast therapy for psoriasis: Time to consider routine TB screening? (PubMed, Australas J Dermatol)
    We describe a case of M.tuberculosis reactivation shortly after commencement of apremilast for psoriasis. We are recommending clinicians perform LTBI risk assessment in all patients, and appropriate LTBI screening in select populations prior to apremilast initiation.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    3ms
    HPP737 Substance Balance Study in Human (clinicaltrials.gov)
    P=N/A, N=8, Not yet recruiting, Newsoara Biopharma Co., Ltd.
    New trial
    3ms
    Crisaborole combined with vitamin D demonstrates superior therapeutic efficacy over either monotherapy in mice with allergic contact dermatitis. (PubMed, Sci Rep)
    The combination of vitamin D and crisaborole significantly reduces inflammation and epidermal hyperkeratosis in a mouse model of allergic contact dermatitis, demonstrating superior therapeutic efficacy compared to either treatment alone. This suggests that the combined therapy could be a promising approach for the prevention and treatment of allergic contact dermatitis.
    Preclinical • Journal
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CCL2 (Chemokine (C-C motif) ligand 2) • IL17A (Interleukin 17A) • CCR2 (C-C Motif Chemokine Receptor 2) • IL4 (Interleukin 4)
    3ms
    Eucrisa for Atopic Dermatitis (clinicaltrials.gov)
    P1, N=28, Active, not recruiting, Wake Forest University Health Sciences | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Aug 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Adherence
    3ms
    MN-166-GBM-1201: Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma (clinicaltrials.gov)
    P1/2, N=50, Active, not recruiting, MediciNova | Trial completion date: Jun 2024 --> Dec 2024
    Trial completion date
    |
    temozolomide • Eyevinal (ibudilast)
    3ms
    Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS (clinicaltrials.gov)
    P2, N=36, Completed, MediciNova | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Aug 2024
    Trial completion • Trial completion date
    |
    Eyevinal (ibudilast)
    3ms
    A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, Verona Pharma plc
    New P2 trial
    3ms
    Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis (clinicaltrials.gov)
    P=N/A, N=106, Not yet recruiting, Chinese Academy of Medical Sciences, Fuwai Hospital
    New trial
    4ms
    A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis (clinicaltrials.gov)
    P3, N=542, Completed, Acrotech Biopharma Inc. | Active, not recruiting --> Completed
    Trial completion
    4ms
    A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities (clinicaltrials.gov)
    P1, N=46, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    4ms
    Adherence to Otezla (clinicaltrials.gov)
    P1, N=84, Not yet recruiting, Wake Forest University Health Sciences | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Adherence
    4ms
    Pilot Study of the Effect of Ibudilast on Neuroinflammation in Methamphetamine Users (clinicaltrials.gov)
    P2, N=120, Recruiting, VA Office of Research and Development | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    Eyevinal (ibudilast)
    4ms
    Difamilast, a Topical Phosphodiesterase 4 Inhibitor, Produces Soluble ST2 via the AHR-NRF2 Axis in Human Keratinocytes. (PubMed, Int J Mol Sci)
    Additionally, the knockdown of AHR or NRF2 abolished the difamilast-induced sST2 production. These results indicate that difamilast treatment produces sST2 via the AHR-NRF2 axis, contributing to improving AD symptoms by inhibiting IL-33 activity.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL13 (Interleukin 13) • IL5 (Interleukin 5) • IL33 (Interleukin 33) • ST2 (Suppression Of Tumorigenicity)
    4ms
    A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov)
    P2, N=240, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P2 trial
    4ms
    A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food (clinicaltrials.gov)
    P1, N=18, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    4ms
    FIBRONEER™-ON: A Follow-up Study to Test Long-term Treatment With BI 1015550 in People With Pulmonary Fibrosis Who Took Part in a Previous Study With BI 1015550 (clinicaltrials.gov)
    P3, N=1700, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    4ms
    A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    4ms
    EBULO: A 20-Week Multicentre, Open Study Assessing the Efficacy and Safety of Apremilast in Patients > 6 Years of Age With EB Simplex Generalized (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Centre Hospitalier Universitaire de Nice
    New P2 trial