CompletedPhase 2

Safety and Efficacy of Nemolizumab in PN

Austria, France70 participantsStarted 2017-10-02

Plain-language summary

The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female of at least 18 years at screening
✓. Clinical diagnosis of PN for at least 6 months with:
✓. Severe pruritus defined as follows on a Numerical Rating Scale (NRS)
✓. Female subjects must fulfill one of the criteria below:

Exclusion criteria

✕. Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
✕. Unilateral lesions of prurigo (e.g only one arm affected)
✕. Cutaneous bacterial or viral infection within 1 week before the baseline visit.
✕. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively,
✕. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease

What they're measuring

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach

Timeframe: Baseline, Week 4

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method

Timeframe: Baseline, Week 4

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data

Timeframe: Baseline, Week 4

Trial details

NCT IDNCT03181503

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-26

Results submitted2019-10-07

View on ClinicalTrials.gov More Prurigo Nodularis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female of at least 18 years at screening
✓. Clinical diagnosis of PN for at least 6 months with:
✓. Severe pruritus defined as follows on a Numerical Rating Scale (NRS)
✓. Female subjects must fulfill one of the criteria below:

Exclusion criteria

✕. Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
✕. Unilateral lesions of prurigo (e.g only one arm affected)
✕. Cutaneous bacterial or viral infection within 1 week before the baseline visit.
✕. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively,
✕. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease

What they're measuring

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach

Timeframe: Baseline, Week 4

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method

Timeframe: Baseline, Week 4

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data

Timeframe: Baseline, Week 4