Systemic Lupus Erythematosus
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CLINICAL_TRIALS trial_result · 2023-07-21Clinical Trial Update: A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) [Phase 2]
Phase 2 trial evaluating safety and efficacy of elsubrutinib and upadacitinib alone or in combination in moderately to severely active syste…
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CLINICAL_TRIALS trial_result · 2023-07-19Clinical Trial Update: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus [Phase 1]
Phase 1 clinical trial evaluating safety, tolerability, PK/PD, and immunogenicity of efavaleukin alfa in systemic lupus erythematosus has co…
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CLINICAL_TRIALS trial_result · 2023-07-03Clinical Trial Update: Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia [Phase 2]
Phase 2 trial update investigating telitacicept for systemic lupus erythematosus, including cases with thrombocytopenia.
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CLINICAL_TRIALS trial_result · 2023-06-22Clinical Trial Update: Sequential Belimumab and T-cell Based Therapy in SLE [Phase 4]
Phase 4 clinical trial update investigating sequential belimumab followed by a T-cell based therapy for systemic lupus erythematosus (SLE).
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CLINICAL_TRIALS trial_result · 2023-06-12Clinical Trial Update: Efficacy and Safety of Telitacicept in Early SLE [Phase 4]
Phase 4 clinical trial update evaluating telitacicept for systemic lupus erythematosus, focusing on efficacy and safety.
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CLINICAL_TRIALS trial_result · 2023-05-16Clinical Trial Update: A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) [Phase 3]
Phase 3 study of baricitinib in systemic lupus erythematosus was terminated; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-05-15Clinical Trial Update: Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) [Phase 2]
Phase 2 trial evaluating litifilimab (BIIB059) in cutaneous lupus erythematosus with or without systemic lupus erythematosus has completed a…
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CLINICAL_TRIALS trial_result · 2023-05-12Clinical Trial Update: Acupressure for Fatigue in Systemic Lupus Erythematosus [NA]
A terminated clinical trial investigating acupressure for fatigue in systemic lupus erythematosus with posted results.
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CLINICAL_TRIALS trial_result · 2023-05-11Clinical Trial Update: Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) [Phase 3]
Phase 3 trial update for recombinant human B lymphocyte RC18 given subcutaneously in systemic lupus erythematosus has completed.
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FDA label_change · 2023-05-10FDA Approved: METHYLPREDNISOLONE ACETATE — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for methylprednisolone acetate by Sandoz Inc.
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FDA approval · 2023-05-05FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for hydroxychloroquine sulfate from Sun Pharmaceutical Industries, Inc., updating the approval for t…
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CLINICAL_TRIALS trial_result · 2023-03-30Clinical Trial Update: Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus [Phase 2, Phase 3]
A clinical trial update indicates etonogestrel implants are being studied for preserving ovarian reserve in systemic lupus erythematosus, sp…
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FDA approval · 2023-03-30FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for hydroxychloroquine sulfate filed by Teva Pharmaceuticals USA, Inc., marking an approved change u…
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CLINICAL_TRIALS trial_result · 2023-03-29Clinical Trial Update: Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease [Phase 4]
A Phase 4 clinical trial evaluating combined pneumococcal conjugate and polysaccharide vaccination in adults with inflammatory rheumatic dis…
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CLINICAL_TRIALS trial_result · 2023-03-20Clinical Trial Update: COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases [Phase 3]
Phase 3 trial update for a COVID-19 vaccine studied in immunosuppressed adults with autoimmune diseases, currently completed.
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FDA approval · 2023-02-15FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Benlysta (belimumab) submitted by GlaxoSmithKline LLC.
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FDA approval · 2023-02-15FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for BENLYSTA (belimumab) submitted by GlaxoSmithKline LLC.
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CLINICAL_TRIALS trial_result · 2023-02-08Clinical Trial Update: Mesenchymal Stromal Cells (MSC´s) in Renal Lupus [Phase 2]
A Phase 2 clinical trial evaluating mesenchymal stromal cells for systemic lupus erythematosus and lupus glomerulonephritis.
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CLINICAL_TRIALS trial_result · 2023-01-30Clinical Trial Update: A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus [Phase 3]
Phase 3 trial of baricitinib in systemic lupus erythematosus was terminated; results posted.
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CLINICAL_TRIALS trial_result · 2023-01-17Clinical Trial Update: COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases [Phase 2, Phase 3]
A Phase 2/Phase 3 clinical trial update evaluating a COVID-19 vaccine booster in immunocompromised individuals with rheumatic diseases.
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CLINICAL_TRIALS trial_result · 2023-01-17Clinical Trial Update: Use of Baricitenib to Maintain of Remission [Phase 2, Phase 3]
Clinical trial update for Baricitenib aimed at maintaining remission in lupus and nephritis in Phase 2/Phase 3.
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CLINICAL_TRIALS trial_result · 2023-01-13Clinical Trial Update: Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus [Phase 3]
A long-term safety update for anifrolumab in adults with active systemic lupus erythematosus (Phase 3) has completed with results posted.
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CLINICAL_TRIALS trial_result · 2022-12-30Clinical Trial Update: A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus [Phase 3]
Phase 3 long-term safety and tolerability study of repeated CEP-33457 administration in systemic lupus erythematosus has been terminated wit…
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CLINICAL_TRIALS trial_result · 2022-12-16Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE) [Phase 2]
Phase 2 trial evaluating CEP-33457 for efficacy and safety in systemic lupus erythematosus has completed with results posted.
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CLINICAL_TRIALS trial_result · 2022-11-30Clinical Trial Update: The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in the Treatment of LN [Phase 3]
Phase 3 trial comparing human umbilical cord mesenchymal stem cells with low-dose IL-2 for treatment of systemic lupus erythematosus and lup…