Phase 3 trials of ianalumab for SLE, lupus nephritis now enrolling

Lupus Therapeutics, Novartis team up to run clinical sites in North America

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Three new Phase 3 clinical trials testing the experimental therapy ianalumab in people with systemic lupus erythematosus (SLE) and lupus nephritis are now recruiting patients.

All three trials are being sponsored by Novartis, the company developing ianalumab. Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, recently announced that it will be teaming up with Novartis to help run these trials at sites in North America.

“We believe this collaboration between Lupus Therapeutics and Novartis Pharmaceuticals will provide a significant opportunity to accelerate the development of new treatments and therapies for both SLE and lupus nephritis conditions and are hopeful that this collaboration will pave the way for improved patient outcomes,” Stacie Bell, PhD, executive vice president at Lupus Therapeutics, said in a press release.

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Ianalumab is antibody-based therapy designed to reduce B-cell activity

Ianalumab is an antibody-based therapy designed to reduce the activity of B-cells, a type of antibody-producing immune cell with a central role in the autoimmune attack that drives lupus and other autoimmune disorders.

The therapy does so by two different mechanisms: by blocking the B-cell activating factor (BAFF) receptor, which is required for B-cell survival, and by destroying B-cells directly.

“The recently announced Novartis Phase 3 program is interesting because the treatment being evaluated is a dual mode of action biologic combining BAFF receptor inhibition with B cell depletion and may offer a new treatment option for our community if the studies are successful,” Bell said in an emailed statement to Lupus News Today. “This is the first partnership between Lupus Therapeutics and Novartis, which may extend to other activities to benefit those living with lupus.”

Two of trials — SIRIUS-SLE 1 (NCT05639114) and SIRIUS-SLE 2 (NCT05624749) — are open to people with SLE, 12 and older, who weigh at least 35 kg (about 77 lbs) and have active disease despite standard-of-care treatments such as corticosteroids or anti-malarial medications.

Participants in both studies will be randomly assigned to receive ianalumab by under-the-skin injection once per month or once every three months, or a placebo, on top of their standard treatment. The main goal will be to assess the proportion of patients who experience a reduction in disease severity sufficient to meet the criteria for the SLE Responder Index-4, which is a composite of several different measures of disease severity. To meet this criteria, patients must show improvements in some measures of disease activity, while not worsening in others.

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Clinical trials worldwide now enrolling patients

SIRIUS-SLE 1 is currently recruiting patients at sites in Nevada in the U.S., and in China, Japan, Hungary, and Spain. SIRIUS-SLE 2 is recruiting participants at sites in Kentucky, Tennessee, and Texas in the U.S., and in Korea, Taiwan, Italy, and Australia.

The third study, called SIRIUS-LN (NCT05126277), is open to adults with lupus nephritis, a serious complication of lupus characterized by kidney damage and inflammation.

As in the other two studies, participants will be given ianalumab once per month or once every three months, or a placebo. The main goal is to assess the proportion of patients who achieve a complete renal response (i.e., normalization of kidney damage markers) after 72 weeks (one year and five months).

SIRIUS-LN is enrolling participants at more than 80 locations across the U.S., Mexico, Argentina, Brazil, Chile, Colombia, Czechia, France, Germany, Spain, Hungary, Romania, China, Korea, Malaysia, Singapore, Taiwan, and Thailand.