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Autoimmune & immunology R&D Pipeline

Autoimmune, rheumatology, and immunology biologics in clinical development.

Programs
987

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Autoimmune & immunology: NovaPharmaNews indexes 987 autoimmune & immunology clinical pipeline programs from ClinicalTrials.gov with phase, modality, NCT identifiers, and sponsor company links. Autoimmune, rheumatology, and immunology biologics in clinical development.

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. AB-101

    Artiva Biotherapeutics

    Lupus Nephritis - WHO Class III

    phase 1 small molecule active

    1 trial

  14. AB-101

    Artiva Biotherapeutics

    Rheumatoid Arthritis

    phase 1 small molecule active

    1 trial

  15. ABI-M201

    ASSEMBLY BIOSCIENCES, INC.

    Ulcerative Colitis Chronic Mild

    phase 1 small molecule terminated

    1 trial

  16. AFN50 injection

    The First People's Hospital of Lianyungang

    Autoimmune Diseases

    phase 1 mab active

    1 trial

  17. ALLO-329

    Allogene Therapeutics

    Systemic Lupus Erythematosus (With and Without Nephritis)

    phase 1 gene therapy active

    1 trial

  18. 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

  19. APVO210

    Aptevo Therapeutics

    Psoriasis

    phase 1 mab terminated

    1 trial

  20. ARQ-151- cream 0.3%

    Arcutis Biotherapeutics

    Plaque Psoriasis

    phase 1 small molecule completed

    1 trial

  21. ARQ-154 Foam 0.3%

    Arcutis Biotherapeutics

    Psoriasis

    phase 1 small molecule completed

    1 trial

  22. ART-I02

    BRIGHT MINDS BIOSCIENCES INC.

    Arthritis, Rheumatoid

    phase 1 gene therapy active

    1 trial

  23. ATA3219

    Evidence Based Cataract Study Group

    Lupus Nephritis

    phase 1 small molecule terminated

    1 trial

  24. ATHENA CAR-T

    The First People's Hospital of Lianyungang

    Lupus Erythematosus, Systemic

    phase 1 mab active

    1 trial

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

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

    Takeda

    Systemic Lupus Erythematosus

    phase 1 small molecule terminated

    1 trial

  36. Atorvastatin

    Lakefront Biotherapeutics NV

    Rheumatoid Arthritis

    phase 1 small molecule completed

    1 trial

  37. Azercabtagene zapreleucel (azer-cel)

    TG THERAPEUTICS, INC.

    B-cell Mediated Autoimmune Disorders

    phase 1 small molecule active

    1 trial

  38. BCMA/CD70 CAR-T cells

    Chongqing Precision Biotech Co., Ltd

    Systemic Lupus Erythematosus

    phase 1 mab active

    1 trial

  39. BMS-986202

    Bristol-Myers Squibb

    Psoriasis

    phase 1 small molecule completed

    1 trial

  40. 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

  41. CB-010

    Caribou Biosciences

    Systemic Lupus Erythematosus

    phase 1 small molecule terminated

    1 trial

  42. CBP-307

    S.L

    Autoimmune Diseases

    phase 1 small molecule completed

    2 trials

  43. CBP-307

    Connect Biopharm

    Autoimmune Diseases

    phase 1 small molecule completed

    1 trial

  44. CD19 CAR-T cells

    Chongqing Precision Biotech Co., Ltd

    Systemic Lupus Erythematosus

    phase 1 mab active

    1 trial

  45. CD19 targeted CAR-T cells

    Chongqing Precision Biotech Co., Ltd

    SLE (Systemic Lupus)

    phase 1 mab active

    1 trial

  46. CD19/BCMA in vivo CAR-T

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Autoimmune Diseases

    phase 1 small molecule active

    1 trial

  47. CLN-978

    Cullinan Therapeutics

    Rheumatoid Arthritis (RA

    phase 1 small molecule active

    1 trial

  48. CNCT19 CAR-T cell therapy

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Autoimmune Hemolytic Anemia

    phase 1 mab active

    1 trial

Frequently asked questions

How many autoimmune & immunology pipeline programs are tracked?

987 programs match this therapeutic area based on indication text, program name, and registry metadata.

Where does pipeline data come from?

ClinicalTrials.gov records linked to NovaPharmaNews company profiles. Verify on ClinicalTrials.gov before investment decisions.

Data attribution: Data sources · All pipeline programs

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