Table 2.
Clinical trials targeting TNF superfamily members to treat fibrotic disease.
| NCT Number | Target | Therapeutic | Title | Conditions | Interventions | Sponsor/Collaborators | Phases | Status | Study Results | Results First Posted |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT03747068 | TNF | anti-TNF mAb | The Influence of Biological Treatment on the Short-Term Complications of Surgery in Patients With Inflammatory Bowel Disease. | Ulcerative Colitis Anti TNF Therapy Ileal Pouch Anal Anastomosis (IPAA) |
Drug: Anti-TNF Drug | HaEmek Medical Center, Israel Mount Sinai Hospital, Canada University of Toronto |
Completed | No Results Available | ||
| NCT03180957 | TNF | anti-TNF mAb | Repurposing Anti-TNF for Treating Dupuytren’s Disease | Dupuytren’s Disease | Drug: Adalimumab Drug: Saline |
University of Oxford Department of Health, United Kingdom Wellcome Trust 180 Therapeutics LP |
Phase 2 | Completed | No Results Available | |
| NCT00385086 | TNF | anti-TNF mAb | Lumbar Spinal Fibrosis and TNF Alpha Inhibition | Post Operative Sciatica by Lumbar Spinal Fibrosis | Drug: TNF blocker Drug: Placebo |
Assistance Publique - Hôpitaux de Paris | Phase 3 | Completed | No Results Available | |
| NCT00063869 | TNF | soluble TNFR2-Fc fusion protein | Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Phase 2 | Completed | No Results Available | |
| NCT05323110 | LIGHT | anti-LIGHT mAb | Study of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers | Chronic Inflammatory Disease | Drug: CBS001 Drug: Placebo |
Capella Bioscience Ltd Centessa Pharmaceuticals plc |
Phase 1 | Recruiting | No Results Available | |
| NCT05288504 | LIGHT | anti-LIGHT mAb | A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. | Non-Eosinophilic Asthma | Drug: AVTX-002 Drug: Placebo |
Avalo Therapeutics, Inc. | Phase 2 | Recruiting | No Results Available | |
| NCT04412057 | LIGHT | anti-LIGHT mAb | Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury | COVID-19 Pneumonia Acute Lung Injury ARDS |
Drug: CERC-002 Drug: Placebo |
Aevi Genomic Medicine, LLC, a Cerecor company Avalo Therapeutics, Inc. |
Phase 2 | Completed | Has Results | 4-Mar-22 |
| NCT03169894 | LIGHT | anti-LIGHT mAb | Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn’s Disease or Ulcerative Colitis | Crohn Disease Ulcerative Colitis |
Drug: MDGN-002 | Aevi Genomic Medicine, LLC, a Cerecor company Avalo Therapeutics, Inc. |
Phase 1 | Terminated | No Results Available | |
| NCT01552681 | LTβR | anti-LTβR Fc fusion protein | Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren’s Syndrome | Primary Sjögren’s Syndrome | Biological: Baminercept Other: Placebo |
National Institute of Allergy and Infectious Diseases (NIAID) Autoimmunity Centers of Excellence Biogen |
Phase 2 | Terminated | Has Results | 23-Mar-16 |
| NCT05354349 | TL1A | anti-TL1A mAb | Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023 | Healthy | Drug: PRA023 IV Low Dose Drug: PRA023 SC Drug: Placebo IV Drug: Placebo SC Drug: PRA023 IV High Dose |
Prometheus Biosciences, Inc. altasciences |
Phase 1 | Active, not recruiting | No Results Available | |
| NCT05270668 | TL1A | anti-TL1A mAb | Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease |
Drug: PRA023 IV Device: Companion diagnostic (CDx) Drug: Placebo |
Prometheus Biosciences, Inc. | Phase 2 | Recruiting | No Results Available | |
| NCT05116969 | DR3 | anti-DR3 mAb | A Phase 1 Study of PTX-35 in Healthy Volunteers | Healthy Volunteer | Drug: PTX-35 | Heat Biologics | Phase 1 | Withdrawn | No Results Available | |
| NCT05107492 | TL1A | anti-TL1A mAb | Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants | Inflammatory Bowel Disease | Drug: 450mg Drug: 150mg Drug: Placebo |
Pfizer | Phase 1 | Completed | No Results Available | |
| NCT05013905 | TL1A | anti-TL1A mAb | A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn’s Disease | Crohn Disease | Drug: PRA023 IV Device: Companion diagnostic (CDx) |
Prometheus Biosciences, Inc. | Phase 2 | Recruiting | No Results Available | |
| NCT04996797 | TL1A | anti-TL1A mAb | A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: PRA023 IV Device: Companion Diagnostic (CDx) Testing Other: Placebo |
Prometheus Biosciences, Inc. | Phase 2 | Recruiting | No Results Available | |
| NCT04676178 | TL1A | anti-TL1A mAb | A Study of PRA023 in Healthy Volunteers | Healthy | Drug: PRA023 Other: Placebo |
Prometheus Biosciences, Inc. Celerion |
Phase 1 | Completed | No Results Available | |
| NCT04269538 | TL1A | anti-TL1A mAb | Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants | Healthy | Drug: PF-06480605 Drug: Placebo |
Pfizer | Phase 1 | Completed | No Results Available | |
| NCT04090411 | TL1A | anti-TL1A mAb | A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: 50 mg Induction/Chronic Drug: 450 mg Induction/Chronic Drug: 150 mg Induction/Chronic Other: 0 mg Induction ONLY |
Pfizer | Phase 2 | Active, not recruiting | No Results Available | |
| NCT02840721 | TL1A | anti-TL1A mAb | Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis. | Colitis, Ulcerative | Drug: PF-06480605 | Pfizer | Phase 2 | Completed | Has Results | 19-Jun-19 |
| NCT01989143 | TL1A | anti-TL1A mAb | Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects. | Healthy | Drug: PF-06480605 Drug: Placebo |
Pfizer | Phase 1 | Completed | No Results Available | |
| NCT04905212 | APRIL, BAFF | TACI-Fc fusion protein | A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Telitacicept 160mg Drug: Telitacicept 240mg Drug: Placebo |
RemeGen Co., Ltd. | Phase 2 | Recruiting | No Results Available | |
| NCT04767698 | BAFF | anti-BAFF mAb | Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Belimumab Drug: Short-course Ocrelizumab Drug: Continued Ocrelizumab |
Johns Hopkins University GlaxoSmithKline |
Phase 2 | Terminated | No Results Available | |
| NCT04716231 | APRIL, BAFF | TACI-Fc fusion protein | Atacicept in Subjects With IgA Nephropathy | IgA Nephropathy Berger Disease |
Biological: Atacicept Other: Placebo to match Atacicept |
Vera Therapeutics, Inc. | Phase 2 | Active, not recruiting | No Results Available | |
| NCT04625153 | APRIL, BAFF | TACI-Fc fusion protein | RC18 in Patients With Relapsing Remitting Multiple Sclerosis: Phase II Trial | Multiple Sclerosis, Relapsing-Remitting | Biological: RC18 160mg Biological: RC18 240mg |
RemeGen Co., Ltd. | Phase 2 | Recruiting | No Results Available | |
| NCT04291781 | APRIL, BAFF | TACI-Fc fusion protein | A Study of RC18 Administered Subcutaneously to Subjects With IgA(Immunoglobulin A) Nephropathy | IgA Nephropathy | Biological: RC18 160mg Biological: RC18 240mg Biological: placebo |
RemeGen Co., Ltd. | Phase 2 | Completed | No Results Available | |
| NCT03844061 | BAFF | anti-BAFF mAb | Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis | Drug: Belimumab Drug: Rituximab Other: Placebo Subcutaneous Injection Other: Placebo Infusion Drug: MMF |
Hospital for Special Surgery, New York GlaxoSmithKline |
Phase 2 | Recruiting | No Results Available | |
| NCT03244059 | BAFF | anti-BAFF mAb | Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies | Chronic Obstructive Pulmonary Disease Emphysema |
Biological: Belimumab Drug: Placebo |
University of Alabama at Birmingham GlaxoSmithKline |
Phase 2 | Completed | No Results Available | |
| NCT03016013 | APRIL, BAFF | TACI-Fc fusion protein | A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. | Moderate and Severe RheumatoId Arthritis | Biological: Placebo plus MTX Biological: RC18 160 mg plus MTX |
RemeGen Co., Ltd. | Phase 3 | Active, not recruiting | No Results Available | |
| NCT02882087 | APRIL, BAFF | TACI-Fc fusion protein | A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-𝛼 Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis | Moderate and Severe Rheumatoid Arthritis | Drug: Placebo plus MTX Drug: RC18 160 mg plus MTX |
RemeGen Co., Ltd. | Phase 2 | Terminated | No Results Available | |
| NCT02808429 | APRIL, BAFF | TACI-Fc fusion protein | Efficacy and Safety of Atacicept in IgA Nephropathy | IgA Nephropathy | Drug: Placebo Drug: Atacicept 25 mg Drug: Atacicept 75 mg |
EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany EMD Serono |
Phase 2 | Terminated | Has Results | 25-Feb-21 |
| NCT02062684 | BAFF | anti-BAFF peptibody | BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration | IgA Nephropathy | Drug: Blisibimod Drug: Placebo |
Anthera Pharmaceuticals | Phase 2|Phase 3 | Completed | No Results Available | |
| NCT02052219 | BAFF | anti-BAFF peptibody | BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod Drug: Placebo |
Anthera Pharmaceuticals | Phase 3 | Withdrawn | No Results Available | |
| NCT01676701 | BAFF | anti-BAFF mAb | Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Tabalumab Auto-Injector Drug: Tabalumab Prefilled Syringe |
Eli Lilly and Company | Phase 3 | Terminated | Has Results | 26-Apr-18 |
| NCT01670565 | BAFF | anti-BAFF mAb | Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis | Drug: Belimumab Drug: Mycophenolate Mofetil Other: Placebo Infusion |
Hospital for Special Surgery, New York Human Genome Sciences Inc. |
Phase 2 | Completed | Has Results | 24-May-22 |
| NCT01576549 | BAFF | anti-BAFF mAb | A Study of LY2127399 in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | Phase 2 | Terminated | Has Results | 26-Apr-18 |
| NCT01253291 | BAFF | anti-BAFF mAb | A Study of Japanese Rheumatoid Arthritis Participants | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | Phase 1 | Completed | Has Results | 1-Mar-19 |
| NCT01253226 | BAFF | anti-BAFF mAb | A Study for Japanese Participants With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: LY2127399 (Tabalumab) Drug: Placebo |
Eli Lilly and Company | Phase 1 | Completed | Has Results | 23-Oct-18 |
| NCT01215942 | BAFF | anti-BAFF mAb | An Open Label Study for Participants With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: LY2127399 | Eli Lilly and Company | Phase 3 | Terminated | Has Results | 11-Jun-18 |
| NCT01202773 | BAFF | anti-BAFF mAb | A Study in Participants With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: LY2127399 Drug: Placebo Q4W Drug: Placebo Q2W |
Eli Lilly and Company | Phase 3 | Terminated | Has Results | 14-May-18 |
| NCT01202760 | BAFF | anti-BAFF mAb | A Rheumatoid Arthritis Study in Participants | Rheumatoid Arthritis | Drug: LY2127399 Drug: Placebo |
Eli Lilly and Company | Phase 3 | Completed | Has Results | 25-Apr-18 |
| NCT01198002 | BAFF | anti-BAFF mAb | A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate | Rheumatoid Arthritis | Drug: LY2127399 Drug: Placebo Q2W Drug: Placebo Q4W Drug: Methotrexate |
Eli Lilly and Company | Phase 3 | Terminated | Has Results | 8-May-18 |
| NCT00931086 | BAFF | anti-BAFF mAb | Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99 | Rheumatoid Arthritis | Drug: belimumab | Human Genome Sciences Inc., a GSK Company GlaxoSmithKline |
No longer available | No Results Available | ||
| NCT00882999 | BAFF | anti-BAFF mAb | A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-Remitting Multiple Sclerosis | Drug: LY2127399 Drug: Placebo |
Eli Lilly and Company | Phase 2 | Completed | Has Results | 15-Nov-18 |
| NCT00853762 | APRIL, BAFF | TACI-Fc fusion protein | Atacicept in Multiple Sclerosis Extension Study, Phase II | Relapsing Multiple Sclerosis | Drug: Atacicept 25 mg Drug: Atacicept 75 mg Drug: Atacicept 150 mg |
EMD Serono Merck KGaA, Darmstadt, Germany |
Phase 2 | Terminated | Has Results | 24-May-16 |
| NCT00837811 | BAFF | anti-BAFF mAb | An Open Label Extension Study in Participants With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: LY2127399 | Eli Lilly and Company | Phase 2 | Completed | Has Results | 25-Apr-18 |
| NCT00785928 | BAFF | anti-BAFF mAb | A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy | Rheumatoid Arthritis | Biological: LY2127399 Drug: Placebo |
Eli Lilly and Company | Phase 2 | Completed | Has Results | 10-Jul-18 |
| NCT00689728 | BAFF | anti-BAFF mAb | A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNF𝛼 Inhibitor Therapy | Arthritis, Rheumatoid | Biological: LY2127399 Drug: Placebo |
Eli Lilly and Company | Phase 2 | Completed | Has Results | 6-Dec-18 |
| NCT00664521 | APRIL, BAFF | TACI-Fc fusion protein | Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) | Rheumatoid Arthritis | Biological: Rituximab Drug: Atacicept Drug: Placebo matched to atacicept |
Merck KGaA, Darmstadt, Germany | Phase 2 | Completed | Has Results | 30-Dec-16 |
| NCT00642902 | APRIL, BAFF | TACI-Fc fusion protein | A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) | Relapsing Multiple Sclerosis | Drug: Atacicept Drug: Placebo matched to atacicept |
EMD Serono | Phase 2 | Terminated | Has Results | 24-May-16 |
| NCT00595413 | APRIL, BAFF | TACI-Fc fusion protein | Atacicept in Anti-Tumor Necrosis Factor Alpha-naÏve Subjects With Rheumatoid Arthritis (AUGUST II) | Rheumatoid Arthritis | Drug: Placebo matched to atacicept Drug: Atacicept: with loading dose Drug: Atacicept Biological: Adalimumab |
EMD Serono Merck KGaA, Darmstadt, Germany |
Phase 2 | Completed | Has Results | 17-Feb-16 |
| NCT00583557 | BAFF | anti-BAFF mAb | A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01 | Rheumatoid Arthritis | Drug: belimumab | Human Genome Sciences Inc. | Phase 2 | Terminated | Has Results | 29-Jun-11 |
| NCT00430495 | APRIL, BAFF | TACI-Fc fusion protein | A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I) | Rheumatoid Arthritis | Drug: Atacicept Drug: Placebo matched to atacicept |
EMD Serono Merck KGaA, Darmstadt, Germany |
Phase 2 | Completed | Has Results | 17-Feb-16 |
| NCT00308282 | BAFF | anti-BAFF mAb | A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: LY2127399 Drug: Placebo |
Eli Lilly and Company | Phase 2 | Completed | Has Results | 18-Mar-19 |
| NCT00071812 | BAFF | anti-BAFF mAb | A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: Placebo Drug: Belimumab 1 mg/kg Drug: Belimumab 4 mg/kg Drug: Belimumab 10 mg/kg |
Human Genome Sciences Inc. | Phase 2 | Completed | Has Results | 25-Jun-12 |
| NCT02321280 | RANKL | anti-RANKL mAb | The Efficacy of Denosumab in Active Crohn’s Disease | Crohn Disease | Drug: Denosumab | University of Manitoba University of Toronto McMaster University |
Phase 1 Phase 2 |
Completed | No Results Available | |
| NCT02132026 | RANKL | anti-RANKL mAb | Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis. | Calcific Aortic Stenosis | Drug: Denosumab Drug: Alendronic Acid Drug: Denosumab Placebo Drug: Alendronic Acid Placebo |
University of Edinburgh British Heart Foundation NHS Lothian |
Phase 2 | Completed | No Results Available | |
| NCT00983658 | OX40L | anti-OX40L mAb | A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma | Asthma | Drug: huMAb OX40L Drug: placebo |
Genentech, Inc. | Phase 2 | Completed | No Results Available | |
| NCT02647866 | OX40 | anti-OX40 mAb | Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis | Ulcerative Colitis Digestive System Diseases Colitis, Ulcerative Colitis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Colonic Diseases Autoimmune Disease Abdominal Pain |
Drug: KHK4083 Drug: Placebo |
Kyowa Kirin, Inc. | Phase 2 | Completed | Has Results | 5-Mar-20 |
| NCT03161288 | OX40L | anti-OX40L mAb | A Study of KY1005 in Healthy Volunteers | Immune System Diseases | Drug: KY1005 Drug: Placebo |
Kymab Limited | Phase 1 | Completed | No Results Available | |
| NCT03568162 | OX40L | anti-OX40L mAb | Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis | Moderate to Severe Atopic Dermatitis | Drug: ISB 830 - Part 1 Group 1 Drug: ISB 830 - Part 1 Group 2 Drug: ISB 830 - Part 1 Group 3 Drug: Placebo - Part 1 Group 4 Drug: ISB 830 - Part 2 Group 5 Drug: Placebo - Part 2 Group 6 |
Ichnos Sciences SA Glenmark Pharmaceuticals S.A. |
Phase 2 | Active, not recruiting | Has Results | 28-Jun-22 |
| NCT03703102 | OX40 | anti-OX40 mAb | Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis | Atopic dermatitis | Drug: KHK4083 Drug: Placebo |
Kyowa Kirin, Inc. Kyowa Kirin Co., Ltd. |
Phase 2 | Completed | Has Results | 9-Jun-22 |
| NCT03754309 | OX40L | anti-OX40L mAb | A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis | Dermatitis, atopic | Drug: KY1005 Drug: Placebo |
Kymab Limited | Phase 2 | Completed | No Results Available | |
| NCT04449939 | OX40L | anti-OX40L mAb | A Study of Subcutaneous KY1005 in Healthy Volunteers | Immune System Diseases | Drug: KY1005 | Kymab Limited | Phase 1 | Completed | No Results Available |
Clinical trials in Phases 1-3 targeting TNFSF members or their receptors to treat diseases presenting with fibrosis. Due to the successful results and FDA approval of anti-TNFα therapies, please note that all clinical trials targeting TNFα could not be listed due to space constraints. These additional trials can be found at https://clinicaltrials.gov/.