An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Prurigo Nodularis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501666
• Other study ID #: RD.06.SPR.202685
• Secondary ID: 2019-004293-25
• Status: Completed
• Phase: Phase 3
• Start date: September 11, 2020
• Est. completion date: February 21, 2023

Study information

• Verified date: November 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 21, 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of PN for at least 6 months with: (a) Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs; (b) At least 20 nodules on the entire body with a bilateral distribution; (c) Investigator Global Assessment (IGA) score >= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits

• Severe pruritus defined as follows on the PP NRS: (a) at the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit; (b) at the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is >= 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 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

• Participant is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study

Exclusion Criteria:

• Body weight < 30 kilogram (kg)

• 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

• 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

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• Nemolizumab 30 mg
Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
• Placebo
Participants will receive matching placebo as SC injection.

Locations

Country	Name	City	State
Austria	Galderma Investigational Site	Graz
Austria	Galderma Investigational Site	Linz
Austria	Galderma Investigational Site	Wien
Canada	Galderma Investigational Site	Calgary	AL
Canada	Galderma Investigational Site	London	Ontario
Canada	Galderma Investigational Site	Saskatoon	Saskatchewan
Denmark	Galderma Investigational Site	Aarhus
Denmark	Galderma Investigational Site	Hellerup
Germany	Galderma Investigational Site	Aachen
Germany	Galderma Investigational Site	Augsburg
Germany	Galderma Investigational Site	Bad Bentheim
Germany	Galderma Investigational Site	Berlin
Germany	Galderma Investigational Site	Bonn
Germany	Galderma Investigational Site	Darmstadt
Germany	Galderma Investigational Site	Dresden
Germany	Galderma Investigational Site	Düsseldorf
Germany	Galderma Investigational Site	Eppendorf
Germany	Galderma Investigational Site	Erlangen
Germany	Galderma Investigational Site	Göttingen
Germany	Galderma Investigational Site	Halle
Germany	Galderma Investigational Site	Hamburg
Germany	Galderma Investigational Site	Heidelberg
Germany	Galderma Investigational Site	Kiel
Germany	Galderma Investigational Site	Lübeck
Germany	Galderma Investigational Site	Mainz
Germany	Galderma Investigational Site	Münich
Germany	Galderma Investigational Site	Münich
Germany	Galderma Investigational Site	Münster
Germany	Galderma Investigational Site	Oldenburg
Germany	Galderma Investigational Site	Tübingen
Germany	Galderma Investigational Site	Würzburg
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Gyula
Hungary	Galderma Investigational Site	Kecskemét
Hungary	Galderma Investigational Site	Szeged
Hungary	Galderma Investigational Site	Szolnok
Hungary	Galderma Investigational Site	Zalaegerszeg
Italy	Galderma Investigational Site	Catania
Italy	Galderma Investigational Site	Chieti
Italy	Galderma Investigational Site	Genova
Italy	Galderma Investigational Site	L'Aquila
Italy	Galderma Investigational Site	Modena
Italy	Galderma Investigational Site	Napoli
Italy	Galderma Investigational Site	Parma
Italy	Galderma Investigational Site	Perugia
Italy	Galderma Investigational Site	Roma
Italy	Galderma Investigational Site	Roma
Italy	Galderma Investigational Site	Vicenza
Poland	Galderma Investigational Site	Czestochowa
Poland	Galderma Investigational Site	Gdansk
Poland	Galderma Investigational Site	Gdynia
Poland	Galderma Investigational Site	Katowice
Poland	Galderma Investigational Site	Lódz
Poland	Galderma Investigational Site	Poznan
Poland	Galderma Investigational Site	Rzeszów
Poland	Galderma Investigational Site	Warszawa
Poland	Galderma Investigational Site	Wroclaw
Sweden	Galderma Investigational Site	Solna
United Kingdom	Galderma Investigational Site	Dudley
United Kingdom	Galderma Investigational Site	Glasgow
United Kingdom	Galderma Investigational Site	London
United Kingdom	Galderma Investigational Site	Newcastle Upon Tyne
United States	Galderma Investigational Site	Ann Arbor	Michigan
United States	Galderma Investigational Site	Austin	Texas
United States	Galderma Investigational Site	Baltimore	Maryland
United States	Galderma Investigational Site	Bellaire	Texas
United States	Galderma Investigational Site	Birmingham	Alabama
United States	Galderma Investigational Site	Birmingham	Alabama
United States	Galderma Investigational Site	Chicago	Illinois
United States	Galderma Investigational Site	Cleveland	Ohio
United States	Galderma Investigational Site	Columbus	Georgia
United States	Galderma Investigational Site	Delray Beach	Florida
United States	Galderma Investigational Site	Fairfax	Virginia
United States	Galderma Investigational Site	High Point	North Carolina
United States	Galderma Investigational Site	Hollywood	Florida
United States	Galderma Investigational Site	Johnston	Rhode Island
United States	Galderma Investigational Site	Knoxville	Tennessee
United States	Galderma Investigational Site	Lake Bluff	Illinois
United States	Galderma Investigational Site	Laredo	Texas
United States	Galderma Investigational Site	Largo	Florida
United States	Galderma Investigational Site	Los Angeles	California
United States	Galderma Investigational Site	Macon	Georgia
United States	Galderma Investigational Site	Miami	Florida
United States	Galderma Investigational Site	New York	New York
United States	Galderma Investigational Site	Norman	Oklahoma
United States	Galderma Investigational Site	Pembroke Pines	Florida
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Providence	Rhode Island
United States	Galderma Investigational Site	Raleigh	North Carolina
United States	Galderma Investigational Site	Sacramento	California
United States	Galderma Investigational Site	Saint Joseph	Missouri
United States	Galderma Investigational Site	Saint Louis	Missouri
United States	Galderma Investigational Site	Salt Lake City	Utah
United States	Galderma Investigational Site	San Diego	California
United States	Galderma Investigational Site	San Diego	California
United States	Galderma Investigational Site	Santa Monica	California
United States	Galderma Investigational Site	Springville	Utah
United States	Galderma Investigational Site	Tampa	Florida
United States	Galderma Investigational Site	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Germany,  Hungary,  Italy,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Week 16	PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".	Week 16
Primary	Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >= 2-Point Improvement from Baseline) at Week 16	IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).	Week 16
Secondary	Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)	An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product.	Up to 36 weeks
Secondary	Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS at Week 4		Week 4
Secondary	Proportion of Participants with PP NRS < 2 at Week 16		Week 16
Secondary	Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) NRS at Week 16	SD NRS is an 11-point scale (0 to10) where 0 is "no sleep loss" and 10 is "I did not sleep at all".	Week 16
Secondary	Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS at Week 4		Week 4
Secondary	Proportion of Participants with PP NRS < 2 at Week 4		Week 4
Secondary	IGA Success Rate at Each Visit Through Week 24		At Each Visit Through Week 24
Secondary	Percentage of Pruriginous Lesions with Excoriations/Crusts ((Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 24	PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts.	At Each Visit Through Week 24
Secondary	Percentage of Healed Prurigo Lesions (PAS item 5b) at Each Visit Through Week 24	PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed.	At Each Visit Through Week 24
Secondary	Change from Baseline in Number of Lesions in Representative Area (PAS item 4) at Each Visit Through Week 24	PAS Item 4 is measure of number of lesions in representative area.	Baseline, at each visit through Week 24
Secondary	Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS Through Week 24		Through Week 24
Secondary	Proportion of Participants with PP NRS < 2 Through Week 24		Through Week 24
Secondary	Proportion of Participants with PP NRS < 3 Through Week 24		Through Week 24
Secondary	Percent Change from Baseline in PP NRS Through Week 24		Baseline, through Week 24
Secondary	Absolute Change from Baseline in PP NRS Through Week 24		Baseline, through Week 24
Secondary	Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) NRS Through Week 24	AP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".	Through Week 24
Secondary	Proportion of Participants with AP NRS < 2 from Baseline Through Week 24		Through Week 24
Secondary	Absolute Change from Baseline in AP NRS Through Week 24		Baseline, Through Week 24
Secondary	Percent Change from Baseline in AP NRS Through Week 24		Baseline, Through Week 24
Secondary	Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS Through Week 24		Through Week 24
Secondary	Absolute Change from Baseline in SD NRS Through Week 24		Baseline, through Week 24
Secondary	Percent Change from Baseline in SD NRS Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in Sleep Onset Latency Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 24	Change from baseline in WASO, defined as the duration of wakefulness from the onset of persistent sleep. WASO is assessed with 3 questions: 1) How many times did you wake up due to the symptoms of prurigo nodularis (for example itching, burning), not counting the final time you woke up for the day? 2) In total, how long did the awakenings related to the symptoms of prurigo nodularis (for example itching, burning) last and 3) In total, how long did these awakenings related to other things last (for example to drink water, to go to the bathroom).	Baseline, through Week 24
Secondary	Change from Baseline in Total Awake and Sleep Time Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in Sleep Efficiency Through Week 24	The Sleep Efficiency is the ratio of total sleep time to time in bed. This shall be assessed by responses from the following questions from participant's sleep diary: 1) What time did you get into bed? 2) What time did you try to go to sleep? 3) How long did it take you to fall asleep? 4) What time did you wake up for the day? 5) What time did you get out of bed for the day?	Baseline, through Week 24
Secondary	Change from Baseline in WASO Related to PN Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in Number of WASO Related to PN Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in PN-associated Pain Frequency Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in PN-associated Pain Intensity Through Week 24		Baseline, through Week 24
Secondary	Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 24	For the PGAD, participants will be asked to rate their overall impression of their skin disease (prurigo nodularis) severity using a 5-point scale from "0=clear" to "5=severe".	Week 24
Secondary	Proportion of Participants Satisfied with Study Treatment (Good, Very Good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 24	The PGAT utilizes a 5-point scale with ratings: poor, fair, good, very good, or excellent, for participants to rate the way they feel their skin disease (prurigo nodularis) is responding to the study treatment.	Week 24
Secondary	Proportion of Participants with an Improvement of >= 4 in DLQI Through Week 24	The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).	Through Week 24
Secondary	Change from Baseline in DLQI Through Week 24		Baseline, through Week 24
Secondary	Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 24	HADS is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and >= 11 indicates clinical effects.	Baseline, Week 24
Secondary	Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 24	The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline, Week 24
Secondary	Area Under Curve (AUC) of Nemolizumab in the Serum		Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Secondary	Trough Level (Ctrough) of Nemolizumab in the Serum		Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Secondary	Maximum Serum Concentration (Cmax) of Nemolizumab in Serum		Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Secondary	Half-Life (t1/2) of Nemolizumab in Serum		Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Secondary	Observed Ctrough of Nemolizumab in Serum		Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Secondary	Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab		Baseline, Day 57, Day 113, Day 169/Early Termination