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Autoimmune & immunology · Phase I

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

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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. ATHENA CAR-T

    The First People's Hospital of Lianyungang

    Lupus Erythematosus, Systemic

    phase 1 mab active

    1 trial

  2. Allogeneic CD19/BCMA-targeted CAR-γδT cell injection

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Refractory/Relapsed Systemic Lupus Erythematosus

    phase 1 mab active

    1 trial

  3. An Early-Stage Study in Multiple Clinics of how Afimkibart May Affect the Body’s Processing of Medicines that Rely on Cytochrome P450 Enzymes in Patients with Ulcerative Colitis

    Hoffmann-La Roche

    Active Ulcerative Colitis (UC)

    phase 1 other active

    1 trial

  4. An open label, balanced, randomized, two-treatment, four period, two-sequence, multiple-dose (steady-state), fully-replicate crossover bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritis

    phase 1 other active

    1 trial

  5. An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    ulcerative colitis

    phase 1 other active

    1 trial

  6. An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fed condition.

    Lacuna Pharma Pty Ltd

    ulcerative colitis

    phase 1 other active

    1 trial

  7. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    plaque psoriasis

    phase 1 other active

    1 trial

  8. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fed condition

    Lacuna Pharma Pty Ltd

    plaque psoriasis

    phase 1 other active

    1 trial

  9. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritis

    phase 1 other active

    1 trial

  10. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fed condition.

    Lacuna Pharma Pty Ltd

    Axial spondyloarthritis, Crohn’s disease, Ulcerative colitis, Atopic dermatitis, Rheumatoid arthritis, Psoriatic arthritis

    phase 1 other active

    1 trial

  11. An open-label, randomized, single-dose, two-period, two-treatment, crossover bioequivalence study with GP-IMP-001 in healthy male volunteers under fasting conditions.

    Lacuna Pharma Pty Ltd

    inteneded for treatment of - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs has been inadequate, - severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy and severe psoriatic arthritis in adult patients, - mild-to-moderate Crohn’s disease, either alone or in combination with corticosteroids, in adult patients refractory or intolerant to thiopurines.

    phase 1 other active

    1 trial

  12. Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody

    Takeda

    Systemic Lupus Erythematosus

    phase 1 small molecule terminated

    1 trial

  13. Atorvastatin

    Lakefront Biotherapeutics NV

    Rheumatoid Arthritis

    phase 1 small molecule completed

    1 trial

  14. Azercabtagene zapreleucel (azer-cel)

    TG THERAPEUTICS, INC.

    B-cell Mediated Autoimmune Disorders

    phase 1 small molecule active

    1 trial

  15. BCMA/CD70 CAR-T cells

    Chongqing Precision Biotech Co., Ltd

    Systemic Lupus Erythematosus

    phase 1 mab active

    1 trial

  16. BMS-986202

    Bristol-Myers Squibb

    Psoriasis

    phase 1 small molecule completed

    1 trial

  17. Bimzelx 320 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled syringe, Bimzelx 160 mg solution for injection in pre-filled syringe, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled syringe, Bimzelx 320 mg solution for injection in pre-filled syringe, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in

    Lacuna Pharma Pty Ltd

    Hidradenitis suppurativa, Axial spondyloarthritis, Moderate to Severe Plaque Psoriasis, Psoriatic arthritis

    phase 1 small molecule active

    1 trial

  18. CB-010

    Caribou Biosciences

    Systemic Lupus Erythematosus

    phase 1 small molecule terminated

    1 trial

  19. CBP-307

    Connect Biopharm

    Autoimmune Diseases

    phase 1 small molecule completed

    1 trial

  20. CBP-307

    S.L

    Autoimmune Diseases

    phase 1 small molecule completed

    2 trials

  21. CD19 CAR-T cells

    Chongqing Precision Biotech Co., Ltd

    Systemic Lupus Erythematosus

    phase 1 mab active

    1 trial

  22. CD19 targeted CAR-T cells

    Chongqing Precision Biotech Co., Ltd

    SLE (Systemic Lupus)

    phase 1 mab active

    1 trial

  23. CD19/BCMA in vivo CAR-T

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Autoimmune Diseases

    phase 1 small molecule active

    1 trial

  24. CLN-978

    Cullinan Therapeutics

    Rheumatoid Arthritis (RA

    phase 1 small molecule active

    1 trial

  25. CNCT19 CAR-T cell therapy

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Autoimmune Hemolytic Anemia

    phase 1 mab active

    1 trial

  26. CNCT19 cell injection

    Juventas Cell Therapy

    Neurological Autoimmune Diseases

    phase 1 mab active

    1 trial

  27. CNTY-101

    Century Therapeutics

    Systemic Lupus Erythematosus

    phase 1 mab active

    1 trial

  28. CTX112

    S.A.

    SLE (Systemic Lupus)

    phase 1 mab active

    1 trial

  29. DIPHENHYDRAMINE, METHYLPREDNISOLONE, PARACETAMOL, ublituximab, Ublituximab, ublituximab, CETIRIZINE, DEXAMETHASONE

    TG THERAPEUTICS, INC.

    Relapsing multiple sclerosis, Myasthenia Gravis

    phase 1 small molecule active

    1 trial

  30. Delayed Release 6 mercaptopurine

    Teva Pharma GmbH

    Crohns Disease

    phase 1 small molecule completed

    1 trial

  31. Dose Escalation Study with Bispecific Antibodies in Adult Patients with Lupus Nephritis

    Lacuna Pharma Pty Ltd

    Lupus Nephritis

    phase 1 other active

    1 trial

  32. EP-104IAR

    EUPRAXIA PHARMACEUTICALS INC.

    Osteoarthritis, Knee

    phase 1 small molecule completed

    1 trial

  33. Effect of Renal Impairment on Enpatoran Pharmacokinetics

    Merck Sharp and Dohme

    Healthy volunteers and patients with renal impairment; Intended indication: autoimmune diseases; systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), as well as dermatomyositis (DM) and polymyositis (PM).

    phase 1 other active

    1 trial

  34. Etrasimod Arginine Blue

    Pfizer Australia Pty Ltd

    Ulcerative Colitis and immune-mediated inflammatory disorders

    phase 1 small molecule active

    1 trial

  35. FT819 in B-cell Mediated Autoimmune Diseases

    Zafatek

    B-cell Mediated Autoimmune Diseases

    phase 1 other active

    1 trial

  36. FX201

    Pacira Ireland Limited

    Osteoarthritis, Knee

    phase 1 mab active

    1 trial

  37. Fasinumab AI

    Regeneron UK Limited

    Osteoarthritis, Knee

    phase 1 small molecule completed

    1 trial

  38. GLPG0634, Jyseleca 200 mg film-coated tablets, Jyseleca 100 mg film-coated tablets

    Alfasigma S.p.A.

    juvenile idiopathic arthritis

    phase 1 small molecule active

    1 trial

  39. GLPG1972 600 mg oral solution fasted

    Lakefront Biotherapeutics NV

    Osteoarthritis

    phase 1 small molecule completed

    1 trial

  40. GLPG1972 cohort 1

    Lakefront Biotherapeutics NV

    Osteoarthritis

    phase 1 small molecule completed

    1 trial

  41. GLPG3667

    Lakefront Biotherapeutics NV

    Plaque Psoriasis

    phase 1 small molecule completed

    1 trial

  42. GLPG3970 film-coated tablet

    Lakefront Biotherapeutics NV

    Systemic Lupus Erythematosus

    phase 1 small molecule terminated

    1 trial

  43. GRT-1C102: A randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of GRT-001 after subcutaneous administrations to healthy subjects (MONOSqut trial).

    Rani Therapeutics Holdings

    Ulcerative colitis

    phase 1 other active

    1 trial

  44. GS-0272

    Gilead Sciences Ireland UC

    Rheumatoid Arthritis

    phase 1 small molecule active

    1 trial

  45. HN2301 injection

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Systemic Lupus Erythematosus

    phase 1 small molecule active

    1 trial

  46. HN2302 Injection

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Autoimmune Disease

    phase 1 small molecule active

    1 trial

  47. Human Umbilical Mesenchymal Stem Cells

    The First People's Hospital of Lianyungang

    Osteoarthritis, Knee

    phase 1 mab active

    1 trial

  48. Humanized TNFα monoclonal antibody

    Sunshine Guojian Pharmaceutical (Shanghai) Co.,

    Rheumatoid Arthritis

    phase 1 small molecule completed

    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.

Data attribution: Data sources · All pipeline programs

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