STUDY DESIGN

The largest controlled clinical trial program in PN to date1-3

OLYMPIA 1 and OLYMPIA 2 are randomized, placebo-controlled, pivotal Phase 3 trials that evaluated NEMLUVIO in adults aged ≥18 years who had moderate-to-severe PN for ≥6 months. A total of 286 adults with PN were enrolled in OLYMPIA 1 for a treatment period of 24 weeks, while 274 were enrolled in OLYMPIA 2 for 16 weeks.

OLYMPIA 2

Image showing that OLYMPIA 2 is a randomized, placebo-controlled, pivotal Phase 3 trial that evaluated NEMLUVIO® in adults aged ≥18 years who had moderate-to-severe PN for ≥6 months.
Image showing that OLYMPIA 2 is a randomized, placebo-controlled, pivotal Phase 3 trial that evaluated NEMLUVIO® in adults aged ≥18 years who had moderate-to-severe PN for ≥6 months.

PRIMARY ENDPOINTS

At Week 16, proportion of patients achieving:

  • ≥4-point improvement from baseline PP-NRS score from baseline
  • IGA of 0 or 1 and ≥2-point improvement from baseline

SELECT SECONDARY ENDPOINTS

Proportion of patients achieving:

  • ≥4-point improvement from baseline in PP-NRS score at Week 4
  • PP-NRS score <2 at Week 16
  • ≥4-point improvement from baseline in SD-NRS at Week 16
  • ≥4-point improvement from baseline in SD-NRS at Week 4
  • PP-NRS score <2 at Week 4
  • PAS item 5b (76% to 100% healed prurigo lesions)

OLYMPIA 2 shares the same entry criteria and endpoints as OLYMPIA 1, with the primary differences being the treatment period and number of patients evaluated.1

OLYMPIA Long-Term Extension (LTE) Study Design6

The OLYMPIA LTE is an ongoing prospective, multicenter, single-arm, open-label study up to 184 weeks. The objective is to assess the long-term safety and efficacy of NEMLUVIO in patients with PN.

The OLYMPIA LTE enrolled patients from OLYMPIA 1 and 2, as well as Phase 2 trials, for a total of 508 patients. As of March 2023, 313 patients completed a Week 52 assessment.*

Image showing that OLYMPIA LTE is an ongoing prospective, multicenter, single­ arm, open­-label study lasting up to 184 weeks. The objective is to assess the long­-term safety and efficacy of NEMLUVIO® in patients with moderate­-to­-severe prurigo nodularis.
Image showing that OLYMPIA LTE is an ongoing prospective, multicenter, single­ arm, open­-label study lasting up to 184 weeks. The objective is to assess the long­-term safety and efficacy of NEMLUVIO® in patients with moderate­-to­-severe prurigo nodularis.

Fast Itch Relief7

See how NEMLUVIO significantly improved itch in both pivotal and long-term studies7

VIEW THE DATA  

Lasting Skin Healing7

Discover how NEMLUVIO healed most PN nodules for patients with PN7

SEE THE DIFFERENCE 

IMPORTANT SAFETY INFORMATION

INDICATIONS: NEMLUVIO® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for:

  • the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
  • the treatment of adults with prurigo nodularis.

CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.

WARNINGS AND PRECAUTIONS:
Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO.

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥1%) are:

  • Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia. 
  • Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular. 

USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women. The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug- associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus.

Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis.

Please see full Prescribing Information, including Patient Information.