Pipeline of drugs being evaluated in phase II clinical trials for SLE19
| Drug | Mechanism of action | Overview of phase II development in SLE* |
| Aldesleukin (ILT-101) | IL-2 | Evaluate the efficacy, safety and pharmacokinetics of ILT-101 in moderate-to-severe SLE. Trial is currently recruiting patients. |
| Baricitinib (LY3009104) | JAK inhibitor | Evaluate the safety and efficacy of baricitinib for patients with SLE. Trial is ongoing. |
| BIIB059 | Anti-BDCA2 monoclonal antibody | Efficacy of BIIB059 in reducing skin disease activity for patients with SLE and cutaneous lupus erythematosus with or without systemic manifestations. Trial is currently recruiting patients. |
| BI655064 | Anti-CD40 monoclonal antibody | Dosage finding, efficacy and safety of BI655064 for patients with active lupus nephritis. Trial is currently recruiting patients. |
| Bortezomib | Proteasome inhibitor | Change in disease-specific antibody titres with bortezomib. Trial is currently recruiting patients. |
| BT063 | Anti–IL-10 monoclonal antibody | Efficacy and safety of BT063 for patients with SLE. Trial is ongoing. |
| Cenerimod (ACT-334441) | Sphingosine-1-phosphate receptor agonist | Biological activity, safety, tolerability and pharmacokinetics of ACT-334441 for patients with SLE. Trial has been completed; no results posted. |
| Dapirolizumab pegol | Anti-CD40L | Efficacy and safety of dapirolizumab for patients with moderate-to-severe SLE. Trial is currently recruiting patients. |
| Edratide | Peptide based on complementary-determining region I of a human anti-DNA monoclonal antibody | In a 26-week phase II trial, no significant difference was observed between edratide-treated and placebo-treated patients in reduction in SLEDAI-2K and adjusted mean SLEDAI, although positive trends were noted for other endpoints.67 Trial is completed, and results are published. |
| Filgotinib | JAK1 inhibitor | Efficacy of filgotinib for female patients with moderate-to-severe active cutaneous lupus erythematosus. Trial is currently recruiting patients. Efficacy and safety of filgotinib in adults with lupus membranous neuropathy. Trial has not begun recruiting. |
| GS-9876 | SYK inhibitor | Efficacy of GS-9876 for female patients with moderate-to-severe active cutaneous lupus erythematosus. Trial is currently recruiting patients. Efficacy and safety of GS-9876 in adults with lupus membranous neuropathy. Trial has not begun recruiting. |
| Iberdomide (CC-220) | Ubiquitin ligase modulator | Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of CC-220 for patients with SLE. A pilot study is ongoing, with a phase II trial currently recruiting patients. |
| IFN-α-kinoid | Anti-IFN-αvaccine | Efficacy, neutralisation of the IFN gene signature and safety of IFN-α-kinoid for patients with SLE. Trial is currently recruiting patients. |
| Iguratimod | Antiinflammatory, NF-κB inhibitor | Efficacy and safety of iguratimod for patients with active diffuse lupus nephritis and refractory lupus nephritis. Studies have not yet started recruiting. |
| Nelfinavir | HIV-1 protease inhibitor | Effect of nelfinavir in reducing anti-dsDNA antibodies. Trial is currently recruiting patients. |
| Obinutuzumab | Anti-CD20 monoclonal antibody | Efficacy and safety of obinutuzumab plus MMF/MPA compared with MMF/MPA-treated placebo for patients with proliferative lupus nephritis. Trial is currently recruiting patients. |
| OMS721 | Anti-MASP-2 monoclonal antibody | Safety and tolerability of OMS721 for patients with lupus nephritis. Trial is currently recruiting patients. |
| Rapamycin (sirolimus) | Immunosuppressant | Two studies have taken place. One was a prospective study evaluating decrease in disease activity and GCS reduction for patients with SLE. The second study evaluated efficacy and safety for patients with idiopathic and lupus-related membranous nephropathy. Trials are completed, and no results are available. |
| RC18 | TACI-antibody fusion protein | Efficacy and safety of RC18 for patients with moderate-to-severe SLE. Trial is currently recruiting patients. |
| RSLV-132 | RNase-Fc fusion protein | Effect of RSLV-132 on cutaneous manifestations for patients with SLE. Trial is currently recruiting patients. |
| SM101 | Soluble Fc-gamma receptor IIb | In a phase IIa trial, the SRI response rate for patients treated with SM101 12 mg/kg once weekly for 4 weeks was approximately twofold higher than placebo at 24 weeks (39% vs 18%).68 |
| Theralizumab (TAB08) | CD28 superagonist (Treg) | Efficacy, safety, pharmacokinetics and pharmacodynamics of TAB08 for patients with SLE not adequately controlled with current concomitant therapy. Trial is currently recruiting patients. |
| Ustekinumab | Anti–IL-12/–23 monoclonal antibody | In a phase II study for patients with active SLE, 60% of patients receiving ustekinumab had an SRI(4) response at week 24 compared with 31% for placebo (P=0.0046).69 |
| Vobarilizumab (ALX-0061) | Anti–IL-6 receptor nanoantibody | Efficacy and safety of vobarilizumab for patients with moderate-to-severe SLE. Trial is ongoing. |
| XmAb5871 | Anti-CD19 monoclonal antibody (B cell) | Efficacy and safety of XmAb5871 for patients with SLE. Trial is currently recruiting patients. |
*Phase I/II trials not reported.
BDCA2, blood dendritic cell antigen-2; dsDNA, double-stranded DNA; GCS; glucocorticosteroid; IFN-α, interferon-α; IL-2, interleukin-2; IL-6, interleukin-6; IL-12, interleukin-12; IL-23, interleukin-23; JAK, Janus kinase; MASP-2, mannan-binding lectin-associated serine protease-2; MMF, mycophenolate mofetil; MPA, mycophenolic acid; NF-κB, nuclear factor kappa-light-chain-enhancer of activated B cells; RNase, ribonuclease; SLEDAI, SLE Disease Activity Index; SLEDAI-2K, modified SLEDAI scale introduced in 2002; SRI(4), SLE Responder Index (SRI) with ≥4 point reductions; SYK, spleen tyrosine kinase; TACI, transmembrane activator and CAML (calcium-modulating cyclophilin ligand) interactor; Treg, T-regulatory cell.