STUDY DESIGN

The largest controlled clinical trial program in PN to date^1-3

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

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.

Assessments & Scales

PEAK PRURITUS NUMERICAL RATING SCALE (PP-NRS)⁴

Patient-reported outcome designed to measure the worst itch over the previous 24-hour period
Treatment success defined as at least a 4-point improvement from baseline

INVESTIGATOR GLOBAL ASSESSMENT (IGA)⁴

Clinician-reported outcome to assess the severity of PN
Scale ranges from 0 (clear) to 4 (severe)
Treatment success defined as 0 (clear) or 1 (almost clear) and a ≥2-point improvement from baseline

SLEEP DISTURBANCE NUMERICAL RATING SCALE (SD-NRS)^4,5

Patient-reported outcome used to evaluate degree of sleep loss the previous night
Treatment success defined as at least a 4-point improvement from baseline

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 moderate-to-severe 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.*

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 PN patients⁷

SEE THE DIFFERENCE

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Interim analysis cutoff date was March 10, 2023.

IGA=Investigator Global Assessment; PAS=prurigo activity score; PN=prurigo nodularis; PP-NRS=Peak Pruritus Numerical Rating Scale; Q4W=every 4 weeks; SD-NRS=Sleep Disturbance Numerical Rating Scale.

References: 1. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024. 2. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.203065; September 2023. 3. Galderma phase Ill data published in The New England Journal of Medicine: full Olympia 2 trial results demonstrate nemolizumab's rapid onset of action in patients with prurigo nodularis. Galderma Laboratories, L.P. Press release. Published October 26, 2023. Accessed April 18, 2024. 4. Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi:10.1002/cti2.1390 5. Ständer S, Fofana F, Dias-Barbosa C, et al. The Sleep Disturbance Numerical Rating Scale: content validity, psychometric validation, and meaningful within-patient change in prurigo nodularis. Dermatol Ther (Heidelb). 2023;13(7):1587-1602. doi:10.1007/13555-023-00962-8 6. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.202865; September 2023. 7. Galderma Laboratories, L.P.; data on file.

IMPORTANT SAFETY INFORMATION

INDICATION: NEMLUVIO^® (nemolizumab-ilto) is an interleukin-31 receptor antagonist indicated for 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 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.

Please see full Prescribing Information, including Patient Information.

STUDY DESIGN

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