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

Sponsor

Galderma R&D (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04501666

Collaborator

(none)

270

Enrollment

110

Locations

Arms

23.7

Anticipated Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prurigo Nodularis	Drug: Nemolizumab 30 mg Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 11, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nemolizumab 30 milligram (mg) Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.	Drug: Nemolizumab 30 mg Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
Placebo Comparator: Placebo Participants weighing < 90 kg will receive matching placebo of two SC injections at baseline, then one SC injection Q4W and participants weighing >= 90 kg will receive matching placebo of two SC injections at baseline, then two SC injections Q4W up to 24 weeks.	Drug: Placebo Participants will receive matching placebo as SC injection.

Arm

Intervention/Treatment

Experimental: Nemolizumab 30 milligram (mg)

Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.

Drug: Nemolizumab 30 mg

Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.

Placebo Comparator: Placebo

Participants weighing < 90 kg will receive matching placebo of two SC injections at baseline, then one SC injection Q4W and participants weighing >= 90 kg will receive matching placebo of two SC injections at baseline, then two SC injections Q4W up to 24 weeks.

Drug: Placebo

Participants will receive matching placebo as SC injection.

Outcome Measures

Primary Outcome Measures

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 [Week 16]
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
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 [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).

Secondary Outcome Measures

Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) [Up to 36 weeks]
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.
Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS at Week 4 [Week 4]
Proportion of Participants with PP NRS < 2 at Week 16 [Week 16]
Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) NRS at Week 16 [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".
Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS at Week 4 [Week 4]
Proportion of Participants with PP NRS < 2 at Week 4 [Week 4]
IGA Success Rate at Each Visit Through Week 24 [At Each Visit Through Week 24]
Percentage of Pruriginous Lesions with Excoriations/Crusts ((Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 24 [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.
Percentage of Healed Prurigo Lesions (PAS item 5b) at Each Visit Through Week 24 [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.
Change from Baseline in Number of Lesions in Representative Area (PAS item 4) at Each Visit Through Week 24 [Baseline, at each visit through Week 24]
PAS Item 4 is measure of number of lesions in representative area.
Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS Through Week 24 [Through Week 24]
Proportion of Participants with PP NRS < 2 Through Week 24 [Through Week 24]
Proportion of Participants with PP NRS < 3 Through Week 24 [Through Week 24]
Percent Change from Baseline in PP NRS Through Week 24 [Baseline, through Week 24]
Absolute Change from Baseline in PP NRS Through Week 24 [Baseline, through Week 24]
Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) NRS Through Week 24 [Through Week 24]
AP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Proportion of Participants with AP NRS < 2 from Baseline Through Week 24 [Through Week 24]
Absolute Change from Baseline in AP NRS Through Week 24 [Baseline, Through Week 24]
Percent Change from Baseline in AP NRS Through Week 24 [Baseline, Through Week 24]
Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS Through Week 24 [Through Week 24]
Absolute Change from Baseline in SD NRS Through Week 24 [Baseline, through Week 24]
Percent Change from Baseline in SD NRS Through Week 24 [Baseline, through Week 24]
Change from Baseline in Sleep Onset Latency Through Week 24 [Baseline, through Week 24]
Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 24 [Baseline, 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).
Change from Baseline in Total Awake and Sleep Time Through Week 24 [Baseline, through Week 24]
Change from Baseline in Sleep Efficiency Through Week 24 [Baseline, 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?
Change from Baseline in WASO Related to PN Through Week 24 [Baseline, through Week 24]
Change from Baseline in Number of WASO Related to PN Through Week 24 [Baseline, through Week 24]
Change from Baseline in PN-associated Pain Frequency Through Week 24 [Baseline, through Week 24]
Change from Baseline in PN-associated Pain Intensity Through Week 24 [Baseline, through Week 24]
Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 24 [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".
Proportion of Participants Satisfied with Study Treatment (Good, Very Good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 24 [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.
Proportion of Participants with an Improvement of >= 4 in DLQI Through Week 24 [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).
Change from Baseline in DLQI Through Week 24 [Baseline, through Week 24]
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 24 [Baseline, 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.
Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 24 [Baseline, 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).
Area Under Curve (AUC) of Nemolizumab in the Serum [Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225]
Trough Level (Ctrough) of Nemolizumab in the Serum [Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225]
Maximum Serum Concentration (Cmax) of Nemolizumab in Serum [Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225]
Half-Life (t1/2) of Nemolizumab in Serum [Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225]
Observed Ctrough of Nemolizumab in Serum [Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225]
Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab [Baseline, Day 57, Day 113, Day 169/Early Termination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational Site	Birmingham	Alabama	United States	35233
2	Galderma Investigational Site	Birmingham	Alabama	United States	35244
3	Galderma Investigational Site	Scottsdale	Arizona	United States	85258
4	Galderma Investigational Site	Los Angeles	California	United States	90045
5	Galderma Investigational Site	Sacramento	California	United States	95815
6	Galderma Investigational Site	San Diego	California	United States	92121
7	Galderma Investigational Site	San Diego	California	United States	92130
8	Galderma Investigational Site	Santa Monica	California	United States	94404
9	Galderma Investigational Site	Delray Beach	Florida	United States	33484
10	Galderma Investigational Site	Hollywood	Florida	United States	33021
11	Galderma Investigational Site	Largo	Florida	United States	33770
12	Galderma Investigational Site	Miami	Florida	United States	33125
13	Galderma Investigational Site	Pembroke Pines	Florida	United States	33028
14	Galderma Investigational Site	Tampa	Florida	United States	33607
15	Galderma Investigational Site	Columbus	Georgia	United States	31904
16	Galderma Investigational Site	Macon	Georgia	United States	31217
17	Galderma Investigational Site	Newnan	Georgia	United States	30263
18	Galderma Investigational Site	Chicago	Illinois	United States	60613
19	Galderma Investigational Site	Lake Bluff	Illinois	United States	60044
20	Galderma Investigational Site	Topeka	Kansas	United States	66614
21	Galderma Investigational Site	Baltimore	Maryland	United States	21231
22	Galderma Investigational Site	Ann Arbor	Michigan	United States	48109
23	Galderma Investigational Site	Saint Joseph	Missouri	United States	64506
24	Galderma Investigational Site	Saint Louis	Missouri	United States	63110
25	Galderma Investigational Site	Henderson	Nevada	United States	89052
26	Galderma Investigational Site	West Orange	New Jersey	United States	07052
27	Galderma Investigational Site	New York	New York	United States	10065
28	Galderma Investigational Site	High Point	North Carolina	United States	27262
29	Galderma Investigational Site	Raleigh	North Carolina	United States	27617
30	Galderma Investigational Site	Winston-Salem	North Carolina	United States	27104
31	Galderma Investigational Site	Cleveland	Ohio	United States	44106
32	Galderma Investigational Site	Norman	Oklahoma	United States	73071
33	Galderma Investigational Site	Philadelphia	Pennsylvania	United States	19103
34	Galderma Investigational Site	Philadelphia	Pennsylvania	United States	19104
35	Galderma Investigational Site	Johnston	Rhode Island	United States	02919
36	Galderma Investigational Site	Providence	Rhode Island	United States	02903
37	Galderma Investigational Site	Knoxville	Tennessee	United States	37909
38	Galderma Investigational Site	Austin	Texas	United States	78738
39	Galderma Investigational Site	Bellaire	Texas	United States	77401
40	Galderma Investigational Site	Laredo	Texas	United States	78401
41	Galderma Investigational Site	Salt Lake City	Utah	United States	84117
42	Galderma Investigational Site	Springville	Utah	United States	84663
43	Galderma Investigational Site	Fairfax	Virginia	United States	22031
44	Galderma Investigational Site	Lynchburg	Virginia	United States	24501
45	Galderma Investigational Site	Graz		Austria	8036
46	Galderma Investigational Site	Linz		Austria	4020
47	Galderma Investigational Site	Wien		Austria	1220
48	Galderma Investigational Site	Calgary	AL	Canada	T3E OB2
49	Galderma Investigational Site	London	Ontario	Canada	N6A 3H7
50	Galderma Investigational Site	Saskatoon	Saskatchewan	Canada	S7K OH6
51	Galderma Investigational Site	Aarhus		Denmark	8200
52	Galderma Investigational Site	Copenhagen		Denmark	2400
53	Galderma Investigational Site	Hellerup		Denmark	2900
54	Galderma Investigational Site	Aachen		Germany	52074
55	Galderma Investigational Site	Augsburg		Germany	86179
56	Galderma Investigational Site	Bad Bentheim		Germany	48455
57	Galderma Investigational Site	Berlin		Germany	10117
58	Galderma Investigational Site	Bonn		Germany	53105
59	Galderma Investigational Site	Darmstadt		Germany	64283
60	Galderma Investigational Site	Dresden		Germany	01307
61	Galderma Investigational Site	Düsseldorf		Germany	40225
62	Galderma Investigational Site	Eppendorf		Germany	20246
63	Galderma Investigational Site	Erlangen		Germany	91054
64	Galderma Investigational Site	Göttingen		Germany	37075
65	Galderma Investigational Site	Halle		Germany	06120
66	Galderma Investigational Site	Hamburg		Germany	20537
67	Galderma Investigational Site	Heidelberg		Germany	69115
68	Galderma Investigational Site	Kiel		Germany	24105
69	Galderma Investigational Site	Lübeck		Germany	23538
70	Galderma Investigational Site	Mainz		Germany	55131
71	Galderma Investigational Site	Münich		Germany	80337
72	Galderma Investigational Site	Münich		Germany	80802
73	Galderma Investigational Site	Münster		Germany	48149
74	Galderma Investigational Site	Oldenburg		Germany	26133
75	Galderma Investigational Site	Regensburg		Germany	93053
76	Galderma Investigational Site	Tübingen		Germany	72076
77	Galderma Investigational Site	Würzburg		Germany	97080
78	Galderma Investigational Site	Budapest		Hungary	1036
79	Galderma Investigational Site	Gyula		Hungary	5700
80	Galderma Investigational Site	Kecskemét		Hungary	6000
81	Galderma Investigational Site	Szeged		Hungary	6720
82	Galderma Investigational Site	Szolnok		Hungary	5000
83	Galderma Investigational Site	Zalaegerszeg		Hungary	8900
84	Galderma Investigational Site	Catania		Italy	95123
85	Galderma Investigational Site	Chieti		Italy	66100
86	Galderma Investigational Site	Genova		Italy	16132
87	Galderma Investigational Site	L'Aquila		Italy	67100
88	Galderma Investigational Site	Modena		Italy	41124
89	Galderma Investigational Site	Napoli		Italy	80131
90	Galderma Investigational Site	Parma		Italy	43126
91	Galderma Investigational Site	Perugia		Italy	06129
92	Galderma Investigational Site	Roma		Italy	00144
93	Galderma Investigational Site	Roma		Italy	00168
94	Galderma Investigational Site	Vicenza		Italy	24128
95	Galderma Investigational Site	Czestochowa		Poland	42-202
96	Galderma Investigational Site	Gdańsk		Poland	80-382
97	Galderma Investigational Site	Gdynia		Poland	81-537
98	Galderma Investigational Site	Katowice		Poland	40-040
99	Galderma Investigational Site	Poznań		Poland	60-702
100	Galderma Investigational Site	Rzeszów		Poland	30-055
101	Galderma Investigational Site	Warszawa		Poland	01-192
102	Galderma Investigational Site	Wrocław		Poland	50-381
103	Galderma Investigational Site	Łódź		Poland	90-127
104	Galderma Investigational Site	Solna		Sweden	17176
105	Galderma Investigational site	Stockholm		Sweden	11883
106	Galderma Investigational Site	Birmingham		United Kingdom	B15 2GW
107	Galderma Investigational Site	Dudley		United Kingdom	DY1 2HQ
108	Galderma Investigational Site	Glasgow		United Kingdom	G3 8SJ
109	Galderma Investigational Site	London		United Kingdom	SE1 9RT
110	Galderma Investigational Site	Newcastle Upon Tyne		United Kingdom	NE1 4LP

Sponsors and Collaborators

Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galderma R&D

ClinicalTrials.gov Identifier:

NCT04501666

Other Study ID Numbers:

RD.06.SPR.202685
2019-004293-25

First Posted:

Aug 6, 2020

Last Update Posted:

Jun 30, 2022

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prurigo

Neurodermatitis

Study Results

No Results Posted as of Jun 30, 2022