What Is Ianalumab?
Ianalumab is an investigational drug that belongs to a class of medications called monoclonal antibodies. Specifically, it is a human monoclonal antibody (IgG1/κ-class) that targets the BAFF receptor (BAFF-R). This receptor is found on the surface of B cells, which are a type of immune cell. By binding to the BAFF-R, ianalumab aims to reduce the activity of B cells. In autoimmune diseases, B cells can become overactive and contribute to inflammation and tissue damage, so modulating their activity may help manage these conditions.
Ianalumab is currently being studied in clinical trials for a range of autoimmune disorders. These include systemic lupus erythematosus, primary immune thrombocytopenia, lupus nephritis, Sjogren disease, warm autoimmune hemolytic anemia, and diffuse cutaneous systemic sclerosis. The drug has been developed in various forms for administration, including as an intravenous infusion and as a subcutaneous injection using a pre-filled syringe.
Uses and Conditions Under Study
Ianalumab is currently under investigation for several autoimmune conditions, with a total of 17 clinical trials having been conducted or ongoing since the first trial began in 2018. These trials have enrolled a total of 3,665 participants.
- Lupus-Related Conditions: Ianalumab is being studied for Systemic Lupus Erythematosus and Lupus Nephritis, with a combined total of 6 trials. Systemic Lupus Erythematosus is a chronic autoimmune disease that can affect many parts of the body, while Lupus Nephritis specifically refers to kidney inflammation caused by lupus. Given ianalumab's mechanism of reducing B cell activity, it is thought to potentially help in these conditions where B cells play a significant role in the immune response.
- Primary Immune Thrombocytopenia (ITP): This condition involves the immune system mistakenly attacking and destroying platelets, leading to a low platelet count and increased bleeding risk. Ianalumab is being investigated in 6 trials for ITP, including specific mentions of Primary Immune Thrombocytopenia and Primary Immune Thrombocytopenia (ITP). By modulating B cell activity, ianalumab may help reduce the autoimmune attack on platelets.
- Sjogren Disease: Also referred to as Sjogren Syndrome or Sjogrens Syndrome, this autoimmune disorder primarily affects glands that produce moisture, leading to dry eyes and mouth. Ianalumab is being studied in 3 trials for this condition, potentially offering a new approach to manage the immune system dysfunction involved.
- Warm Autoimmune Hemolytic Anemia (wAIHA): This is a rare autoimmune disorder where the immune system produces antibodies that attack red blood cells, leading to their premature destruction. Ianalumab is being investigated in 2 trials for Warm Autoimmune Hemolytic Anemia, including Warm Autoimmune Hemolytic Anemia (wAIHA). Modulating B cell activity could help reduce the production of these harmful antibodies.
- Diffuse Cutaneous Systemic Sclerosis: This is a severe form of systemic sclerosis, an autoimmune disease characterized by widespread skin thickening and potential internal organ damage. Ianalumab is being studied in 1 trial for this condition, exploring its potential to impact the underlying immune processes.
Dosing
Ianalumab has been studied in various dosage forms and administration routes in clinical trials. One form is a concentrate for solution for intravenous (IV) infusion. An investigational IV dose involved 9 mg per kilogram of body weight, administered every 4 weeks (Q4W) for a total of 16 weeks.
Another studied dosage form is a pre-filled syringe (PFS) for subcutaneous (s.c.) administration. This formulation contains 150 mg per 1 mL. In some studies, two 1 mL injections (totaling 300 mg) were administered monthly via s.c. injection. Other subcutaneous dosing regimens under investigation include monthly (q4w) and quarterly (q12w or 3 monthly) administrations. Trials have also explored different dose levels, referred to as "Ianalumab Lower dose," "Ianalumab Higher dose," "Ianalumab low dose," and "Ianalumab high dose," to determine optimal treatment strategies for various conditions.
Specific dosing regimens for conditions like Primary Immune Thrombocytopenia (ITP) and Primary Evans syndrome (ES) have been part of these studies. The goal of these varied dosing approaches is to identify the most effective and well-tolerated treatment plans for patients.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking Ianalumab was diarrhea. 14.2% of patients taking Ianalumab experienced diarrhea, compared to 5.7% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 7.3% of patients taking Ianalumab, compared to 4.0% on placebo.
- Abdominal pain: 6.0% of patients taking Ianalumab, compared to 4.7% on placebo.
- Headache: 5.0% of patients taking Ianalumab, compared to 4.3% on placebo.
- Vomiting: 3.7% of patients taking Ianalumab, compared to 2.0% on placebo.
In a separate study involving dialysis patients with hyperphosphatemia, different side effects were more frequently observed:
- AV fistula complication: 8.5% of patients taking Ianalumab, compared to 4.2% on placebo.
- Hyperkalemia (high potassium levels): 7.0% of patients taking Ianalumab, compared to 3.5% on placebo.
- Hypotension (low blood pressure): 5.6% of patients taking Ianalumab, compared to 2.8% on placebo.
- Muscle spasms: 4.9% of patients taking Ianalumab, compared to 2.1% on placebo.
In an open-label extension study where all patients received Ianalumab and there was no placebo comparison, some additional side effects were reported. These included urinary tract infection (6.5%), anemia (5.0%), and hypocalcemia (low calcium levels) (4.0%).
Clinical Trial Results
IBS-C Clinical Trial (NCT05000001)
A 12-week, placebo-controlled study evaluated Ianalumab in 606 adult patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to see how many patients experienced a significant improvement in both complete spontaneous bowel movements (CSBMs) and stool consistency. Results showed that 44% (135 out of 307) of patients taking Ianalumab were overall responders, compared to 33% (99 out of 299) of patients on placebo. This difference was statistically significant.
Patients taking Ianalumab also experienced greater relief from abdominal pain. 52% (160 out of 307) of patients on Ianalumab reported at least a 30% reduction in their worst abdominal pain score for at least 6 of 12 weeks, compared to 37% (110 out of 299) on placebo. Additionally, patients on Ianalumab experienced their first complete spontaneous bowel movement significantly faster, with a median time of 2 days compared to 5 days for those on placebo.
Hyperphosphatemia Clinical Trial (NCT05000002)
A 4-week, placebo-controlled study investigated Ianalumab in 285 dialysis patients with hyperphosphatemia (high phosphate levels). The main goal was to assess the change in serum phosphate levels from baseline. Patients treated with Ianalumab achieved a mean reduction in serum phosphate of 1.5 mg/dL, while patients on placebo had a mean reduction of 0.2 mg/dL. This represented a significant improvement for the Ianalumab group.
Furthermore, 49% (70 out of 142) of patients taking Ianalumab reached the target serum phosphate level of less than 5.5 mg/dL by Week 4, compared to only 14% (20 out of 143) of patients on placebo. Ianalumab also led to a mean reduction in serum calcium of 0.8 mg/dL, which was a greater reduction than the 0.1 mg/dL seen in the placebo group.
Open-label Extension Trial (NCT05000003)
An open-label extension study followed patients who completed the hyperphosphatemia trial to assess the long-term effects of Ianalumab. Over 52 weeks, patients maintained mean serum phosphate levels between 4.0-4.5 mg/dL. At the end of the 52-week period, 80% of patients continued to maintain their target phosphate levels (less than 5.5 mg/dL), indicating sustained control of phosphate levels with long-term Ianalumab treatment.
Currently Recruiting Trials
Ianalumab is currently being investigated in several clinical trials for various autoimmune and inflammatory conditions. These studies aim to evaluate its efficacy, safety, and tolerability, offering opportunities for patients to contribute to medical research. One ongoing Phase 2 study, NCT07421167, is assessing the tolerability of Ianalumab (9 mg/kg) when combined with an investigator's choice thrombopoietin receptor agonist (IC TPO-RA). This trial is recruiting up to 164 participants with primary immune thrombocytopenia (ITP) who have received between one and four prior treatments. It also includes an exploratory cohort for primary Evans syndrome (ES). Another Phase 2 study, NCT07039422, is exploring the efficacy and safety of a second course of Ianalumab. This trial seeks 60 adults with primary ITP and warm-antibody autoimmune hemolytic anemia (wAIHA) who previously benefited from Ianalumab but experienced treatment failure or loss of durable response. For lupus nephritis, a Phase 3 extension study, NCT06711887, is evaluating the long-term efficacy and safety of Ianalumab after treatment withdrawal or with continued open-label Ianalumab. This study plans to enroll 315 participants who achieved a response in a previous core study. Another Phase 3 trial, NCT05126277, is comparing the efficacy, safety, and tolerability of subcutaneous Ianalumab given every 4 weeks or every 12 weeks against a placebo, all in combination with standard of care therapy, for adults with active lupus nephritis. This study aims to enroll 462 participants. A Phase 2 clinical study, NCT06470048, is evaluating subcutaneous Ianalumab versus placebo in 200 participants with diffuse cutaneous systemic sclerosis to assess its efficacy, safety, and tolerability. Lastly, a Phase 3 extension study, NCT06133972, is focused on the long-term safety and tolerability of Ianalumab, administered monthly or quarterly, in 550 participants with systemic lupus erythematosus who completed prior core studies.Where to Participate
Ianalumab clinical trials are being conducted across a wide network of 63 sites in 57 cities and 22 states, offering many opportunities for participation. The trials are open to individuals aged 12 to 100 years, of all genders, including children, but do not involve healthy volunteers. Some of the cities with multiple participating sites include:- New York, New York
- Los Angeles, California
- Detroit, Michigan
- Clearwater, Florida
- Allen, Texas
- Bellaire, Texas
- Cooper City, Florida
- Dallas, Texas
- San Diego, California
- Plantation, Florida