Phase 3 N=274 Randomized Double-blind Treatment

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Prurigo Nodularis

Bottom Line

View on ClinicalTrials.gov: NCT04501679 ↗

Enrolled (actual)

274

Serious AEs

3.3%

Results posted

Jul 2024

Primary outcome: Primary: Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 — 103; 19 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nemolizumab (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16	103; 19	<0.0001 sig
PRIMARY Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16	69; 10	<0.0001 sig
SECONDARY Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4	75; 7	<0.0001 sig
SECONDARY Number of Participants With PP NRS < 2 at Week 16	64; 7	<0.0001 sig
SECONDARY Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16	95; 19	<0.0001 sig
SECONDARY Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4	68; 9	<0.0001 sig
SECONDARY Number of Participants With PP NRS < 2 at Week 4	36; 2	<0.0001 sig
SECONDARY Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)	112; 48; 21; 9; 4; 5	—

Summary

The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits
Severe pruritus was defined as follows on the PP NRS:
At the screening visit (Visit 1): PP NRS score was >= 7.0 for the 24-hour period immediately preceding the screening visit.
At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was >= 7.0 over the previous week
Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Exclusion Criteria

Body weight less than < 30 kg
Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [eg] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
Unilateral lesions of prurigo (eg, only one arm affected)
History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis)
Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis
Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit
Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit

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Data sourced from ClinicalTrials.gov (NCT04501679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.