What Is Risankizumab?
Risankizumab is an FDA-approved medication for adults with plaque psoriasis, psoriatic arthritis, and Crohn's disease. It is an IL-23-specific inhibitor, meaning it selectively blocks the p19 subunit of the interleukin-23 (IL-23) protein. By doing so, risankizumab helps to reduce inflammation associated with certain immune-mediated conditions.
This drug is also being investigated for other conditions, including ulcerative colitis. A total of 82 clinical trials involving 24,365 participants have studied risankizumab since the first trial began in 2014. The majority of these studies are sponsored by AbbVie, with 65 trials.
Uses and Conditions Under Study
Risankizumab is being studied for its effectiveness in several chronic inflammatory conditions:
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Psoriasis and Psoriatic Arthritis: Psoriasis is a chronic inflammatory disease where skin cells build up, forming thick, red, scaly patches. Psoriatic arthritis (PsA) is a type of arthritis that occurs when the immune system attacks healthy cells and tissues, causing joint pain, stiffness, and swelling. Risankizumab, by targeting IL-23, aims to reduce the inflammation underlying these conditions. A total of 25 trials have focused on psoriasis, and 7 trials have investigated psoriatic arthritis, including juvenile PsA.
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Inflammatory Bowel Disease (IBD): This category includes Crohn's disease (CD) and ulcerative colitis (UC), both chronic inflammatory conditions affecting the digestive tract. Crohn's disease can cause inflammation anywhere from the mouth to the anus, while ulcerative colitis primarily affects the colon and rectum. Risankizumab is being evaluated for its ability to reduce inflammation and symptoms in these conditions. There are 25 trials across Crohn's disease and ulcerative colitis, including studies in pediatric participants.
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Healthy Volunteers: Studies involving 14 trials with healthy volunteers are conducted to understand how risankizumab moves through the body (pharmacokinetics) and to assess its safety profile in individuals without the target conditions.
Risankizumab concentrations in breast milk are also being assessed in lactating women with IBD to evaluate safety during pregnancy and breastfeeding.
Dosing
Risankizumab has been studied in two primary forms: intravenous (IV) infusion and subcutaneous (SC) injection. The subcutaneous form has been investigated using both prefilled syringes and on-body injectors. An investigational microdevice, designed to test drugs directly on skin conditions, has also been studied in relation to risankizumab.
Subcutaneous strengths have included 18 mg, 75 mg, 90 mg, 150 mg, 180 mg, 300 mg, 360 mg, and 600 mg. Intravenous strengths have ranged from 200 mg to 1800 mg. Dosing regimens vary by condition and study phase. Induction doses are often given more frequently, such as at Weeks 0, 4, and 16, followed by maintenance doses, which may be administered every 8 weeks or every 12 weeks, depending on the condition and specific study protocol.
Specific doses of risankizumab are also being investigated for pediatric participants with conditions like Crohn's disease, ulcerative colitis, and plaque psoriasis. Some trials have explored risankizumab in combination with other medications, such as adalimumab, ustekinumab, vedolizumab, apremilast, bimekizumab, sonelokimab, and methotrexate.
Side Effects
In clinical trials, the most common side effects reported with Risankizumab were infections and pain. The frequency of these side effects varied across different studies and patient populations.
- Nasopharyngitis (common cold symptoms) was reported in 16.1% of patients taking Risankizumab in some trials, compared to 17.2% on placebo. In other trials, 4.8% of patients experienced nasopharyngitis, compared to 3.5% on placebo.
- Viral upper respiratory tract infection occurred in 10.0% of patients on Risankizumab, compared to 9.7% on placebo.
- Upper respiratory tract infection was observed in 7.2% of patients taking Risankizumab, versus 7.1% on placebo.
- Arthralgia (joint pain) was reported in 6.5% of patients on Risankizumab in some studies, compared to 5.1% on placebo. In other studies, 3.7% of patients experienced arthralgia, compared to 5.5% on placebo.
- Headache affected 5.5% of patients taking Risankizumab, compared to 3.4% on placebo. In another set of trials, headache was reported in 5.4% of patients on Risankizumab, compared to 5.2% on placebo.
- Back pain occurred in 4.2% of patients on Risankizumab, compared to 3.9% on placebo.
- Influenza was reported in 2.9% of patients taking Risankizumab, compared to 2.1% on placebo.
- Nausea was experienced by 3.6% of patients on Risankizumab, compared to 4.5% on placebo.
Less commonly, anemia was reported in 2.5% of patients on Risankizumab compared to 4.6% on placebo.
Clinical Trial Results
Crohn's Disease
In a study (NCT02031276) of patients with active, moderate-to-severe Crohn's disease, Risankizumab demonstrated significant improvements at Week 12:
- Clinical response: 41.5% of patients receiving Risankizumab 600 mg intravenously achieved clinical response, compared to 23.1% on placebo.
- Clinical remission: 36.6% of patients on Risankizumab 600 mg achieved clinical remission, compared to 15.4% on placebo.
- Endoscopic remission: 19.5% of patients on Risankizumab 600 mg achieved endoscopic remission, compared to 2.6% on placebo.
- Deep remission: 12.2% of patients on Risankizumab 600 mg achieved deep remission, while 0% of patients on placebo did.
A long-term extension trial (NCT02513459) for Crohn's disease patients showed sustained improvements with Risankizumab 180 mg subcutaneous (SC) dosing. Over various visits, the percentage of patients achieving clinical remission (based on CDAI) ranged from approximately 71% to 88%. Patient-reported outcomes also showed improvement, with abdominal pain scores decreasing by an average of 1.3 to 1.9 units and stool frequency decreasing by an average of 3.6 to 4.6 liquid stools per week from baseline. Mucosal healing was observed in approximately 30% to 44% of patients at different time points.
Ankylosing Spondylitis
A dose-finding study (NCT02047110) in patients with ankylosing spondylitis showed the following at Week 12:
- ASAS 20 improvement: 45.0% of patients receiving Risankizumab 18 mg achieved at least 20% improvement in disease activity (ASAS 20), compared to 20.0% on placebo.
- BASDAI score reduction: Patients on Risankizumab 18 mg experienced a median reduction of 1.2 units in their BASDAI score (a measure of disease activity), compared to a 0.6 unit reduction on placebo.
- ASAS 40 improvement: At Week 24, 23.1% of patients on Risankizumab 90 mg achieved at least 40% improvement (ASAS 40), compared to 15.0% on placebo.
Chronic Plaque Psoriasis
In an extension trial (NCT02203851) for moderate to severe chronic plaque psoriasis, patients who continued treatment with Risankizumab showed high rates of skin clearance at Week 48:
- PASI 100: 55.6% of patients on Risankizumab 90 mg achieved 100% improvement in their Psoriasis Area and Severity Index (PASI
Currently Recruiting Trials
Risankizumab is being investigated in several clinical trials for various inflammatory conditions. These studies aim to understand its effects, safety, and how it works in the body across different patient populations, including children and adults.
- A Phase 3 study, NCT07071519, is recruiting 120 young participants with ulcerative colitis to learn more about how risankizumab works, its safety, and effectiveness. This AbbVie-sponsored trial explores various dosages to understand the drug's movement through the body.
- Another AbbVie-sponsored Phase 3 study, NCT06880744, is comparing risankizumab to vedolizumab in 530 adult participants with moderate to severe ulcerative colitis. The goal is to assess changes in disease activity and overall safety.
- For adults with active psoriatic arthritis, a Phase 2 study, NCT06865105, is evaluating the efficacy and safety of targeted therapies, including risankizumab monotherapy and combination therapies. This AbbVie trial aims to enroll 120 participants.
- The University Medical Center Groningen is conducting a Phase 1/Phase 2 study, NCT06606808, to image risankizumab-800CW in 18 participants with inflammatory bowel disease (Crohn's disease and ulcerative colitis). This study investigates how the drug moves through the body using fluorescence imaging.
- An observational study, NCT06298188, sponsored by Shaare Zedek Medical Center, is exploring the real-life short and longer-term outcomes of risankizumab in 90 children with Crohn's disease.
- A Phase 3 study, NCT06641089, is comparing sonelokimab with placebo and risankizumab in 600 adults with active psoriatic arthritis who have not responded well to anti-TNFα therapy.
- AbbVie is also sponsoring a Phase 2 study, NCT06548542, for 540 adult participants with moderate to severe Crohn's disease. This study evaluates risankizumab as a monotherapy and in combination with other targeted therapies.
- A Phase 3 AbbVie study, NCT06100744, is assessing risankizumab compared to adalimumab in 40 children with juvenile psoriatic arthritis, focusing on adverse events, disease activity, and how the drug moves through the body.
- The VOICE study, NCT06249555, is a prospective observational study enrolling 300 participants with Crohn's disease to explore the early response to vedolizumab and IL-23 antagonists, including risankizumab.
- For pediatric participants with moderately to severely active Crohn's disease, an AbbVie-sponsored Phase 3 study, NCT05995353, is recruiting 110 individuals to assess the pharmacokinetics, efficacy, and safety of intravenous and subcutaneous risankizumab.
- The PATHFINDER trial, NCT05928039, a Phase 4 study from the University of Calgary, is enrolling 297 participants with moderate-to-severe ileal-dominant Crohn's disease to determine the optimal first-line treatment strategy among different biologic classes, including anti-IL-23 agents.
- Finally, a registry study, NCT04846959, is comparing pregnancy outcomes in 818 women exposed to risankizumab with those not exposed, across various FDA-approved indications like plaque psoriasis, psoriatic arthritis, and Crohn's disease.
Where to Participate
Clinical trials for risankizumab are widely accessible across the United States, with study sites in 37 states and 157 cities. There are currently 195 recruiting sites available for interested participants.
The cities with the most active recruiting sites include:
- New York, New York (5 sites)
- Miami, Florida (5 sites)
- Orlando, Florida (5 sites)
- San Antonio, Texas (4 sites)
- Houston, Texas (4 sites)
- Tampa, Florida (4 sites)
- Lubbock, Texas (3 sites)
- Indianapolis, Indiana (3 sites)
- San Diego, California (3 sites)
- Mansfield, Texas (3 sites)
Eligibility for these studies generally includes individuals between 2 and 80 years of age, of all genders. While healthy volunteers are typically not sought for these trials, many studies are open to children.
Development Timeline
The journey of risankizumab began with its first clinical trial on January 9, 2014, marking the start of a comprehensive development program primarily driven by AbbVie, which has sponsored 65 of the 82 total trials. The latest trial is projected to conclude on March 30, 2026.
Over this period, risankizumab has been investigated in a total of 82 trials, enrolling 24,365 participants. The development has progressed through various phases, with 33 trials reaching Phase 3, 17 in Phase 1, and 15 in Phase 2, demonstrating a robust advancement through the clinical pipeline.
Initially, the drug's development focused on conditions like IBS-C and hyperphosphatemia. However, the pipeline quickly expanded to address a broader range of inflammatory and autoimmune diseases. Key indications now include Crohn's Disease, Ulcerative Colitis, Psoriatic Arthritis, and Plaque Psoriasis, reflecting a strategic expansion to target significant unmet medical needs. The research has also extended to specific populations, such as children with Juvenile Psoriatic Arthritis and pediatric Crohn's Disease, showcasing a commitment to diverse patient care.