Sun Pharma announces positive phase 3 results evaluating tildrakizumab 100 mg in active psoriatic arthritis

Sun Pharma announces positive phase 3 results evaluating tildrakizumab 100 mg in active psoriatic arthritis

By, Admin 22 July 2025

Overview

Sun Pharmaceutical Industries Limited announced top-line results from two phase 3 clinical studies evaluating the efficacy and safety of tildrakizumab 100 mg (Ilumya) administered over 24 weeks for treatment of active psoriatic arthritis (PsA).

About the study

Treatment with tildrakizumab 100 mg (Ilumya) resulted in greater improvements in PsA signs and symptoms at Week 24 compared to treatment with placebo. Both the INSPIRE-1 and INSPIRE-2 studies achieved the primary endpoint, with a higher proportion of patients in the INSPIRE-1 and INSPIRE-2 studies treated with tildrakizumab achieving ACR20 responses at week 24, compared to those receiving placebo (p < 0.05).

Statement from Marek Honczarenko, SVP, Sun Pharma

We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints. These top-line results reinforce the therapeutic potential of Ilumya as a treatment option for patients with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data in the near future,” said Marek Honczarenko, MD, PhD, senior vice president and head of global specialty development at Sun Pharma.

Safety data from study

Safety data in the studies was consistent with the well-documented safety profile of Ilumya, which is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies.
 
Result presentation of INSPIRE trials 

Findings from the INSPIRE studies will be presented at upcoming medical conferences and published in a peer- reviewed medical journal. Use of tildrakizumab 100 mg (in psoriatic arthritis is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

The INSPIRE-1 and INSPIRE-2 trials

  • The INSPIRE-1 and INSPIRE-2 are both 52-week global, multicenter, randomized, double-blind, single-dose, placebo-controlled Phase 3 studies aimed at assessing the efficacy and safety of tildrakizumab 100 mg (Ilumya) in adult patients with active psoriatic arthritis. 
  • The INSPIRE-1 enrolled patients having prior exposure to an anti- TNF agent while the INSPIRE-2 enrolled anti-TNF naïve patients. 
  • A total of over 800 adult patients were enrolled for the two studies from clinical sites in the US, Europe and Asia. Patients were randomized to receive either tildrakizumab 100 mg or placebo. An induction dose was not administered in either study. 
  • Study participants were permitted to use concomitant methotrexate or leflunomide, provided the dose remained stable throughout the trial. 
  • In the INSPIRE-1 and INSPIRE-2 studies, tildrakizumab 100 mg was administered at Week 0 and then every 12 weeks. 
  • In contrast, in phase 3 studies for chronic plaque psoriasis, the treatment schedule included doses in Week 0, Week 4, and then every 12 weeks thereafter. Ilumya is approved by the regulatory Agencies for the indication of chronic plaques psoriasis.
  • The primary endpoint for both studies is the proportion of participants achieving an ACR20 response at Week 24. The key secondary efficacy endpoints at 24 weeks include ACR50, ACR70, and PASI75 and improvement. 

Understanding ACR Response Criteria in Rheumatology

  • The ACR20 is a composite measure defined as a 20 per cent improvement in both the number of tender and number of swollen joints and a 20 per cent improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure (most often HAQ-DI), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). 
  • ACR50 and ACR70 are the same measurement with improvement levels of 50 per cent and 70 per cent, respectively.

Psoriatic arthritis

  • Psoriatic arthritis (PsA) is a chronic (long-lasting or recurring) disease related to the immune system. It causes swelling, pain, and stiffness in joints and entheses (places where tendons and ligaments connect to bones). 
  • Psoriatic arthritis can develop at any age. Psoriatic arthritis can occur regardless of the severity of psoriasis (mild, moderate, or severe). 
  • Roughly 1 in 3 people living with psoriasis also have psoriatic arthritis; typically, with psoriasis developing before psoriatic arthritis. 
  • While as many as 2.4 million Americans live with psoriatic arthritis, more than 15% of people living with psoriasis may also have undiagnosed psoriatic arthritis.

About the antibody: Ilumya

  • Ilumya (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. 
  • Ilumya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States and other countries.

 
Ilumya: Indications- Ilumya (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
 
Ilumya: Contraindications- Ilumya is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

About the company: Sun Pharma

  • Sun Pharma is the world’s leading specialty generics company with a presence in specialty, generics and consumer healthcare products. 
  • It is the largest pharmaceutical company in India and is a leading generic company in the US as well as global emerging markets. 
  • Sun Pharma’s high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales.

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