Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04183335
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 151
• Locations: 63
• Arms: 2
• Actual Duration (Months): 25.8
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in patients with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in patients with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable To demonstrate efficacy of dupilumab on skin lesions of PN To demonstrate the improvement in health-related quality of life To evaluate safety outcome measures To evaluate immunogenicity of dupilumab

Condition or Disease	Intervention/Treatment	Phase
Neurodermatitis	Drug: Dupilumab SAR231893; Drug: Placebo; Drug: Moisturizers; Drug: Low to medium potent topical corticosteroids; Drug: Topical calcineurin inhibitors	Phase 3

Detailed Description

The duration of study for each participant will include 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
• Actual Study Start Date: Dec 12, 2019
• Actual Primary Completion Date: Nov 12, 2021
• Actual Study Completion Date: Feb 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dupilumab Dose regimen 1 on top of moisturizers and if applicable low to medium potent topical corticosteroids or topical calcineurin inhibitors	Drug: Dupilumab SAR231893; Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Drug: Moisturizers; Pharmaceutical form: Route of administration: Topical; Drug: Low to medium potent topical corticosteroids; Pharmaceutical form: Route of administration: Topical; Drug: Topical calcineurin inhibitors; Pharmaceutical form: Route of administration: Topical
Placebo Comparator: Matched placebo Placebo on top of moisturizers and if applicable low to medium potent topical corticosteroids or topical calcineurin inhibitors	Drug: Placebo; Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Drug: Moisturizers; Pharmaceutical form: Route of administration: Topical; Drug: Low to medium potent topical corticosteroids; Pharmaceutical form: Route of administration: Topical; Drug: Topical calcineurin inhibitors; Pharmaceutical form: Route of administration: Topical

Outcome Measures

Primary Outcome Measures

1. Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 24 [Baseline to Week 24]

   WI-NRS is a patient-reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

Secondary Outcome Measures

1. Time to onset of effect on pruritus as measured by proportion of participants with an improvement (reduction) in WI-NRS by ≥4 from baseline during the 24-week treatment period [Baseline to Week 24]

   WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

2. Change from baseline in WI-NRS [Baseline to Week 12 and Week 24]

   WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

3. Percent change from baseline in WI-NRS [Baseline to Week 2, Week 4, Week 12 and Week 24]

   WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

4. Percent change from baseline in WI-NRS over time [Baseline to overtime until Week 24]

   WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

5. Proportion of participants with improvement (reduction) in WI-NRS reduction ≥4 [Week 4 and Week 12]

   WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

6. Proportion of participants with WI-NRS reduction ≥ 4 over time until Week 24 [Baseline to overtime until Week 24]

   WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

7. Onset of action in change from baseline in WI-NRS [Baseline to overtime until Week 12]

   Onset of action in change from baseline in WI-NRS (first p<0.05 difference from placebo in the daily WI-NRS that remains significant at subsequent measurements) until Week 12. WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

8. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-stage at Week 24 [Week 24]

   Investigator's global assessment for prurigo nodularis (IGA PN) is a clinician reported outcome (ClinRO) that allows clinicians to assess the stage of the disease (IGA PN-S) using a 5-point scale from 0 (clear) to 4 (severe).

9. Proportion of participants with IGA PN-S 0 or 1 score at Week 4, 8 and 12 [Week 4, Week 8 and Week 12]

   IGA PN is a ClinRO that allows clinicians to assess IGA PN-S using a 5-point scale from 0 (clear) to 4 (severe).

10. Change from baseline in IGA PN-S score [Baseline to Week 4, Week 8, Week 12 and Week 24]

    IGA PN is a ClinRO that allows clinicians to assess IGA PN-S using a 5-point scale from 0 (clear) to 4 (severe).

11. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Activity (IGA PN-A) [Week 4, Week 8, Week 12, and Week 24]

    IGA PN is a ClinRO that allows clinicians to assess the activity of PN (IGA PN-A) using a 5-point scale from 0 (clear) to 4 (severe).

12. Change from baseline in health-related quality-of-life, (HRQoL), as measured by Dermatology Life Quality Index (DLQI) [Baseline to Week 12 and Week 24]

    The DLQI is a PRO developed to measure dermatology-specific HRQoL in adult patients. Overall scoring ranges from 0 to 30, with a high score indicative of a poor HRQoL.

13. Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24 [Baseline through Week 24]

    Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24.

14. Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time [Baseline through Week 24]

    Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Must be 18 to 80 years of age, at the time of signing the informed consent.

With a clinical diagnosis of PN defined by all of the following:

• Diagnosed by a dermatologist for at least 3 months before the Screening visit

• On the WI-NRS ranging from 0 to 10, patients must have an average worst itch score of ≥7 in the 7 days prior to Day1.

• Patients must have a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at Screening visit and Day 1

• History of failing a 2-week course of medium-to-superpotent topical corticosteroids (TCS) or when TCS are not medically advisable

• Have applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1

• Must be willing and able to complete a daily symptom eDiary for the duration of the study

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes

• PN secondary to medications

• PN secondary to medical conditions such as neuropathy or psychiatric disease

• Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit

• Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the patient's participation in the study

• Severe renal conditions (eg, patients with uremia and/or on dialysis)

• Participants with uncontrolled thyroid disease.

• Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated

• Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.

• Active chronic or acute infection (except HIV infection) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period

• Known or suspected immunodeficiency

• Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number :8400011	Gilbert	Arizona	United States	85234
2	Investigational Site Number :8400022	Fort Smith	Arkansas	United States	72916
3	Investigational Site Number :8400026	Sacramento	California	United States	95816
4	Investigational Site Number :8400014	Miami	Florida	United States	33136
5	Investigational Site Number :8400004	Columbus	Georgia	United States	31904
6	Investigational Site Number :8400003	Newnan	Georgia	United States	30263
7	Investigational Site Number :8400017	Sandy Springs	Georgia	United States	30328
8	Investigational Site Number :8400016	Indianapolis	Indiana	United States	46250
9	Investigational Site Number :8400018	Clarkston	Michigan	United States	48346
10	Investigational Site Number :8400013	Saint Louis	Missouri	United States	63110
11	Investigational Site Number :8400024	East Windsor	New Jersey	United States	08520
12	Investigational Site Number :8400009	Athens	Ohio	United States	45701
13	Investigational Site Number :8400001	Dublin	Ohio	United States	43016
14	Investigational Site Number :8400007	Tulsa	Oklahoma	United States	74136
15	Investigational Site Number :8400010	Philadelphia	Pennsylvania	United States	19104
16	Investigational Site Number :8400015	Charleston	South Carolina	United States	29414
17	Investigational Site Number :8400006	Bellaire	Texas	United States	77401
18	Investigational Site Number :8400025	Houston	Texas	United States	77058
19	Investigational Site Number :8400002	Pflugerville	Texas	United States	78660
20	Investigational Site Number :8400019	San Antonio	Texas	United States	78249
21	Investigational Site Number :8400005	Norfolk	Virginia	United States	23502
22	Investigational Site Number :0320008	Caba	Buenos Aires	Argentina	C1023AAB
23	Investigational Site Number :0320005	Caba	Buenos Aires	Argentina	C1055AAO
24	Investigational Site Number :0320002	Caba	Buenos Aires	Argentina	C1425BEN
25	Investigational Site Number :0320004	Caba	Ciudad De Buenos Aires	Argentina	C1425BEA
26	Investigational Site Number :0320007	Caba	Ciudad De Buenos Aires	Argentina	C1431EKK
27	Investigational Site Number :0320003	San Miguel de Tucuman	Tucumán	Argentina	T4000AXL
28	Investigational Site Number :0320001	Buenos Aires		Argentina	C1121ABE
29	Investigational Site Number :0320006	Caba		Argentina	1425DES
30	Investigational Site Number :0320009	Mendoza		Argentina	M5500
31	Investigational Site Number :1560004	Beijing		China	100050
32	Investigational Site Number :1560001	Chengdu		China	610041
33	Investigational Site Number :1560002	Hangzhou		China	310006
34	Investigational Site Number :1560003	Wuxi		China	214002
35	Investigational Site Number :2500005	Reims		France	51100
36	Investigational Site Number :3920009	Yokohama-shi	Kanagawa	Japan	236-0004
37	Investigational Site Number :3920005	Kyoto-shi	Kyoto	Japan	606-8507
38	Investigational Site Number :3920007	Nagasaki-shi	Nagasaki	Japan	852-8501
39	Investigational Site Number :3920003	Tokorozawa-shi	Saitama	Japan	359-8513
40	Investigational Site Number :3920010	Izumo-shi	Shimane	Japan	693-8501
41	Investigational Site Number :3920004	Bunkyo-ku	Tokyo	Japan	113-8519
42	Investigational Site Number :3920006	Itabashi-ku	Tokyo	Japan	173-8610
43	Investigational Site Number :3920001	Shinagawa-Ku	Tokyo	Japan	141-8625
44	Investigational Site Number :3920002	Nagoya-shi		Japan	454-8509
45	Investigational Site Number :4100007	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
46	Investigational Site Number :4100005	Incheon	Incheon-gwangyeoksi	Korea, Republic of	21431
47	Investigational Site Number :4100002	Seoul	Seoul-teukbyeolsi	Korea, Republic of	03080
48	Investigational Site Number :4100003	Seoul	Seoul-teukbyeolsi	Korea, Republic of	03722
49	Investigational Site Number :4100004	Seoul	Seoul-teukbyeolsi	Korea, Republic of	07441
50	Investigational Site Number :4100001	Incheon		Korea, Republic of	21565
51	Investigational Site Number :4840002	Guadalajara	Jalisco	Mexico	44100
52	Investigational Site Number :4840001	Monterrey	Nuevo León	Mexico	64460
53	Investigational Site Number :4840005	Monterrey	Nuevo León	Mexico	64718
54	Investigational Site Number :4840006	Guadalajara		Mexico	44210
55	Investigational Site Number :4840003	Veracruz		Mexico	91910
56	Investigational Site Number :6430008	Chelyabinsk		Russian Federation	454048
57	Investigational Site Number :6430007	Krasnodar		Russian Federation	350020
58	Investigational Site Number :6430005	Moscow		Russian Federation	107076
59	Investigational Site Number :6430010	Moscow		Russian Federation	115522
60	Investigational Site Number :6430006	Moscow		Russian Federation	125993
61	Investigational Site Number :6430009	Saratov		Russian Federation	410026
62	Investigational Site Number :6430002	St-Petersburg		Russian Federation	197022
63	Investigational Site Number :6430001	Stavropol		Russian Federation	355030

Sponsors and Collaborators

• Sanofi
• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT04183335
• Other Study ID Numbers: EFC16459; 2019-003774-41; U1111-1241-8153
• First Posted: Dec 3, 2019
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 16, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prurigo; Neurodermatitis; Calcineurin Inhibitors

Study Results

No Results Posted as of Feb 17, 2022