New Ipsen-sponsored Study Assessing Itching and Sleep Patterns in PBC patients

On July 3^rd, 2025, Ipsen listed the observational Luminaria study (N=30; SSD: Jun 2025; PCD: Dec 2025), which will assess itch severity and sleep patterns in adult patients with PBC using a digital health tool. Notably, the study will include patients not already enrolled in another clinical study, and treatment with Iqirvo is not a requirement for enrollment.

• During the study, participants will use a digital health sensor (ADAM) for seven nights across four 7-day periods to collect sleep data, as sleep patterns can otherwise be difficult to track
  • The total duration for each patient will be approximately 91 days
• The current study status is listed as “Not yet recruiting”
  • The estimated enrollment is 30 participants
• Primary outcomes include a comprehensive assessment of the frequency and duration of scratching events, and how these events impact sleep quality at Weeks 0, 4, 8, and 12
• Secondary outcomes are as follows:
  • Baseline assessment of patient demographics, including current PBC treatment duration and concomitant itch medications
  • Baseline liver function and liver stiffness measures
  • Pruritus severity and PROs at Weeks 0, 4, 8, and 12  
• No trial sites have been listed yet

 Impact Assessment:

• Ipsen’s initiation of a new observational  study to assess the severity of itchiness and sleep patterns in people with PBC suggests an intention to further differentiate Iqirvo through symptom management, given that efficacy is not superior and Livdelzi’s label already includes improvement in pruritus
• Ipsen may be using the Luminaria study to confirm whether a relationship between pruritus and sleep exists, to promote use of PPARs (such as Iqirvo) for the treatment of both symptoms
  • At EASL 2025, 52-week data from the Phase 3 ELATIVE trial were presented, demonstrating a weak correlation between pruritus and fatigue severity at baseline and at Week 52 despite previous assumptions that the two were closely linked
    • Recently, Ipsen has been messaging on Iqirvo data demonstrating a positive impact on fatigue and excessive sleepiness separately from its impact on pruritus
• Luminaria may be part of Ipsen’s strategy to support Iqirvo benefit in Quality of Life (QoL) measures
  • in Apr 2025, Iqirvo did not receive strong recommendations from France’s HAS or Germany’s G-BA based on biochemical surrogate data
  • This trial aligns with overall themes from PBC competitors at EASL 2025 emphasizing itching and sleep quality as key patient concerns, reflecting Ipsen’s broader investment into improving patient QoL
  • In addition, this study may enable Ipsen to build KOL relationships without the constraints of product-specific promotion, which could foster scientific collaboration in the future