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Autoimmune & immunology · Phase I

Autoimmune & immunology programs at Phase I — ClinicalTrials.gov pipeline intelligence.

Programs
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Autoimmune & immunology Phase I programs: NovaPharmaNews indexes 167 matching clinical development programs from ClinicalTrials.gov with sponsor, modality, and NCT cross-links.

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  1. 1% icotinib hydrochloride cream

    Betta Pharmaceuticals Co.,

    Psoriasis

    phase 1 small molecule completed

    1 trial

  2. 50 mg LX3305 QD

    LEXICON PHARMACEUTICALS, INC.

    Rheumatoid Arthritis

    phase 1 small molecule completed

    1 trial

  3. 608

    Sunshine Guojian Pharmaceutical (Shanghai) Co.,

    Moderate to Severe Plaque Psoriasis

    phase 1 small molecule active

    1 trial

  4. A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients with Ulcerative Colitis

    Lacuna Pharma Pty Ltd

    Ulcerative colitis

    phase 1 other active

    1 trial

  5. A Long-Term Follow-up Study for Subjects Previously Treated with A Century Therapeutics Cellular Therapy Product

    Century Therapeutics

    Hematological or solid tumor malignancies or autoimmune diseases

    phase 1 other active

    1 trial

  6. A Phase 1 Study of CD19-targeted NEX-T CAR T Cells in Participants with RMS, PMS, or MG(Breakfree-2)

    Celgene Europe Limited

    Myasthenia gravis (MG), Progressive Multiple Sclerosis (PMS), Relapsing Multiple Sclerosis (RMS)

    phase 1 other active

    1 trial

  7. A Phase 1 Study of CD19-targeted NEX-T CAR T Cells in Participants with Severe, Refractory Autoimmune Diseases (Breakfree-1)

    Celgene Europe Limited

    Systemic Sclerosis, Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathy, Systemic Lupus Erythematosus (SLE)

    phase 1 other active

    1 trial

  8. A Phase 1 Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants with Severe, Refractory Autoimmune Diseases

    Bristol-Myers Squibb Australia Pty Ltd

    Systemic Sclerosis, Idiopathic Inflammatory Myopathy, Rheumatoid Arthritis, Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  9. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pimozide after Multiple Dose Administration in Subjects with Rheumatoid Arthritis

    Lacuna Pharma Pty Ltd

    rheumatoid arthritis

    phase 1 other active

    1 trial

  10. A Phase 1b open label pilot study of CLN-978 for the treatment of moderate to severe systemic lupus erythematosus (SLE)

    Cullinan Therapeutics

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  11. A Phase I, Open-Label Study of CLN-978 in Patients with Treatment-Refractory Rheumatoid Arthritis (RA)

    Cullinan Therapeutics

    Treatment-Refractory Rheumatoid Arthritis

    phase 1 other active

    1 trial

  12. A Single-Arm, Open-Label, Phase 1 Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Severe, Refractory Systemic Lupus Erythematosus

    Autolus GmbH

    Severe, Refractory Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  13. A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese and Japanese Participants, and Participants with Interstitial Lung Disease Associated with Connective Tissue Disease (CTD-ILD)

    GlaxoSmithKline

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  14. A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants with Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)

    AbbVie Deutschland GmbH & Co. KG

    Systemic Lupus Erythematosus, Sjogren's disease

    phase 1 other active

    1 trial

  15. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants with Systemic Lupus Erythematosus

    Hoffmann-La Roche

    Systemic Lupus Erythematosus (SLE)

    phase 1 other active

    1 trial

  16. A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants with Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.

    AstraZeneca AB

    Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies

    phase 1 other active

    1 trial

  17. A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 are Tolerated and Act in the Body of Healthy Adults

    Pfizer Australia Pty Ltd

    Rheumatoid arthritis and Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  18. A clinical study of MK-1045 in people with lupus or rheumatoid arthritis (MK-1045-004)

    Merck Sharp and Dohme

    Systemic lupus erythematosus, Rheumatoid arthritis

    phase 1 other active

    1 trial

  19. A clinical study of MK-2420 in healthy men (MK-2420-003)

    Merck Sharp and Dohme

    Rheumatoid arthritis

    phase 1 other active

    1 trial

  20. A clinical study of MK-2420 in healthy people (MK-2420-002)

    Merck Sharp and Dohme

    Rheumatoid arthritis

    phase 1 other active

    1 trial

  21. A dose-finding Phase I study of F8IL10 intra-articular treatment in Rheumatoid Arthritis

    Philogen S.p.A.

    Patients with Rheumatoid Arthritis (RA) who, despite treatment with stable doses (for at least 3 months) of disease-modifying antirheumatic drugs (DMARDs, conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for intra-articular (IA) injection in a knee, shoulder, ankle, wrist or elbow.

    phase 1 other active

    1 trial

  22. A double blinded, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine Delayed Release Tablets USP 1.2 g manufactured by Sun Pharmaceutical Industries Limited, India with Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g product of Takeda Canada Inc., in healthy, adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    ulcerative colitis

    phase 1 other active

    1 trial

  23. A double blinded, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine Delayed Release Tablets USP 1.2 g manufactured by Sun Pharmaceutical Industries Limited, India with Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g product of Takeda Canada Inc., in healthy, adult, human subjects under fed condition.

    Lacuna Pharma Pty Ltd

    ulcerative colitis

    phase 1 other active

    1 trial

  24. A first-in-human study to investigate safety and tolerability of SAR446959 in participants with osteoarthritis of the knee

    Sanofi-aventis Healthcare Pty Ltd

    Osteoarthritis

    phase 1 other active

    1 trial

  25. A phase 1 trial to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of VIS171 in participants with autoimmune disease(s)

    Otsuka Beijing Research Institute

    Systemic lupus erythematosus, Immune-mediated focal segmental glomerulosclerosis, Alopecia Areata

    phase 1 other active

    1 trial

  26. A phase Ib, open-label, ascending dose study to assess safety, tolerability and pharmacokinetics of PIT565 in participants with rheumatoid arthritis (RA)

    Novartis Pharmaceuticals

    Rheumatoid Arthritis

    phase 1 other active

    1 trial

  27. A phase Ib, open-label, ascending dose study with step-up doses to assess safety, tolerability, and pharmacokinetics of PIT565 in participants with systemic lupus erythematosus (SLE)

    Novartis Pharmaceuticals

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  28. A placebo-controlled safety and tolerability study of intravenous (IV) and subcutaneous (SC) AZD1163 in healthy volunteers

    AstraZeneca AB

    Rheumatoid Arthritis

    phase 1 other active

    1 trial

  29. A randomized, double-blind, placebo-controlled, single and multiple-dose-escalation, phase 1 study in healthy volunteers and patients with ulcerative colitis to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GRT-001 (MONOlith trial)

    Rani Therapeutics Holdings

    Ulcerative colitis

    phase 1 other active

    1 trial

  30. A study to Learn How Safe AGMB-129 is in Healthy Adults Taking Multiple Doses of AGMB-129 That Are Increased a Little at a Time

    Agomab Therapeutics NV

    Fibrostenotic Crohn’s disease

    phase 1 other active

    1 trial

  31. A study to assess the effect of single and repeated doses of JNJ-81241459 on a single dose of certain other drugs, when given together to healthy adult participants

    Janssen-Cilag International N.V.

    Plaque Psoriasis

    phase 1 other active

    1 trial

  32. A study to compare how the body absorbs different formulations of a new medicine, and how food affects drug absorption, in healthy participants

    Janssen-Cilag International N.V.

    Psoriasis

    phase 1 other active

    1 trial

  33. A study to evaluate how well single and multiple doses of O3R-5671-PRO are tolerated in healthy adult subjects

    Lacuna Pharma Pty Ltd

    Inflammatory bowel diseases and psoriasis.

    phase 1 other active

    1 trial

  34. A study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig in adult participants with rheumatoid arthritis or systemic lupus erythematosus.

    AstraZeneca AB

    Systemic Lupus Erythematosus, Rheumatoid Arthritis

    phase 1 other active

    1 trial

  35. A study to investigate the safety and pharmacological effect of a single intravenous infusion of GSK2857914 in male and female participants aged 18 to 75 with moderate to severe systemic lupus erythematosus

    GlaxoSmithKline

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  36. A study to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in participants with B-cell driven ARD.

    GlaxoSmithKline

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  37. A trial of prednisolone in combination with SPI-62 in participants with polymyalgia rheumatica (PMR)

    Lacuna Pharma Pty Ltd

    polymyalgia rheumatica

    phase 1 other active

    1 trial

  38. AB-101

    Artiva Biotherapeutics

    Lupus Nephritis - WHO Class III

    phase 1 small molecule active

    1 trial

  39. AB-101

    Artiva Biotherapeutics

    Rheumatoid Arthritis

    phase 1 small molecule active

    1 trial

  40. ABI-M201

    ASSEMBLY BIOSCIENCES, INC.

    Ulcerative Colitis Chronic Mild

    phase 1 small molecule terminated

    1 trial

  41. AFN50 injection

    The First People's Hospital of Lianyungang

    Autoimmune Diseases

    phase 1 mab active

    1 trial

  42. ALLO-329

    Allogene Therapeutics

    Systemic Lupus Erythematosus (With and Without Nephritis)

    phase 1 gene therapy active

    1 trial

  43. AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-STAGE CROSSOVER ADAPTIVE BIOEQUIVALENCE STUDY OF TRIAMCINOLONE ACETONIDE 40 MG/ML STERILE INJECTABLE SUSPENSION (Test product–Lisapharma S.p.A) VERSUS KENACORT® 40 MG/ML SUSPENSION (Reference product – Bristol Myers Squibb) AFTER INTRAMUSCULAR ADMINISTRATION TO HEALTHY VOLUNTEERS

    Lacuna Pharma Pty Ltd

    Intramuscular administration of triamcinolone acetonide Lisapharma (Injectable suspension of triamcinolone acetonide) is indicated for systemic corticosteroid therapy in morbid conditions such as allergic syndrome (to control severe or debilitating conditions not treatable in a conventional way), dermatoses, generalized rheumatoid arthritis and other connective tissue diseases.

    phase 1 other active

    1 trial

  44. APVO210

    Aptevo Therapeutics

    Psoriasis

    phase 1 mab terminated

    1 trial

  45. ARQ-151- cream 0.3%

    Arcutis Biotherapeutics

    Plaque Psoriasis

    phase 1 small molecule completed

    1 trial

  46. ARQ-154 Foam 0.3%

    Arcutis Biotherapeutics

    Psoriasis

    phase 1 small molecule completed

    1 trial

  47. ART-I02

    BRIGHT MINDS BIOSCIENCES INC.

    Arthritis, Rheumatoid

    phase 1 gene therapy active

    1 trial

  48. ATA3219

    Evidence Based Cataract Study Group

    Lupus Nephritis

    phase 1 small molecule terminated

    1 trial

Frequently asked questions

How many autoimmune & immunology Phase I programs exist?

167 programs match both the therapeutic area and stage filters in our published index.

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