Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04202679
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 160
• Locations: 57
• Arms: 2
• Actual Duration (Months): 22.2
• Patients Per Site: 2.8
• 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: 160 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: Jan 16, 2020
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Nov 22, 2021

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. Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 [Baseline to Week 12]

   Proportion of participants with improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to Week 12

Secondary Outcome Measures

1. Improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 [Baseline to Week 24]

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

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

   Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Stage (IGA PN-S) at Week 24.

3. Time to onset of effect on pruritus [Baseline to overtime until Week 24]

   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.

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

   Change from baseline in WI-NRS at Week 12 and Week 24

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

   Percent change from baseline in WI-NRS at Week 2, Week 4, Week 12 and Week 24.

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

   Percent change from baseline in WI-NRS over time until Week 24.

7. Proportion of participants with WI-NRS reduction ≥4 at Week 4 [Baseline to Week 4]

   Proportion of participants with WI-NRS reduction ≥4 at Week 4

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

   Proportion of participants with WI-NRS reduction ≥4 over time until Week 24.

9. 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.

10. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-stage [Baseline to Week 4, Week 8 and Week 12]

    Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Stage (IGA PN-S) at Week 4, Week 8 and Week 12.

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

    Change from baseline in IGA PN-S score at Week 4, Week 8, Week 12 and Week 24.

12. Proportion of participants with Investigator's Global Assessment 0 or 1 score for PN-Activity [Baseline to Week 4, Week 8, Week 12, and Week 24]

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

13. Change from baseline in health-related quality-of-life [Baseline to Week 12 and Week 24]

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

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

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

15. Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab over time [Baseline to 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) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and 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 :8400054	Fort Smith	Arkansas	United States	72916
2	Investigational Site Number :8400008	Sacramento	California	United States	95816
3	Investigational Site Number :8400005	Pembroke Pines	Florida	United States	33028
4	Investigational Site Number :8400002	Plainfield	Indiana	United States	46168
5	Investigational Site Number :8400003	Baltimore	Maryland	United States	21205
6	Investigational Site Number :8400006	East Windsor	New Jersey	United States	08520
7	Investigational Site Number :8400001	Sugar Land	Texas	United States	77479
8	Investigational Site Number :1240002	Calgary	Alberta	Canada	T2G 1B1
9	Investigational Site Number :1240006	Surrey	British Columbia	Canada	V3R 6A7
10	Investigational Site Number :1240007	Markham	Ontario	Canada	L3P 1X3
11	Investigational Site Number :1240008	Newmarket	Ontario	Canada	L3Y 5G8
12	Investigational Site Number :1240001	Toronto	Ontario	Canada	M5A 3R6
13	Investigational Site Number :1240009	Saskatoon	Saskatchewan	Canada	S7K 0H6
14	Investigational Site Number :1520005	Valdivia	Los Ríos	Chile	5110683
15	Investigational Site Number :1520006	Osorno	Reg Metropolitana De Santiago	Chile	5311523
16	Investigational Site Number :1520003	Santiago	Reg Metropolitana De Santiago	Chile	7580206
17	Investigational Site Number :1520001	Santiago	Reg Metropolitana De Santiago	Chile	7640881
18	Investigational Site Number :1520004	Santiago	Reg Metropolitana De Santiago	Chile	80004005
19	Investigational Site Number :1520002	Santiago		Chile
20	Investigational Site Number :2500007	Bordeaux		France	33075
21	Investigational Site Number :2500001	Brest		France	29200
22	Investigational Site Number :2500008	Le Mans		France	72037
23	Investigational Site Number :2500002	Lille		France	59037
24	Investigational Site Number :2500006	Lyon		France	69003
25	Investigational Site Number :2500004	Paris		France	75010
26	Investigational Site Number :2500005	Reims		France	51100
27	Investigational Site Number :2500003	Toulouse		France	31059
28	Investigational Site Number :3480004	Debrecen		Hungary	4032
29	Investigational Site Number :3480002	Orosháza		Hungary	5900
30	Investigational Site Number :3480005	Pécs		Hungary	7632
31	Investigational Site Number :3480003	Szeged		Hungary	6720
32	Investigational Site Number :3800001	Rozzano	Milano	Italy	20089
33	Investigational Site Number :3800004	Ancona		Italy	60032
34	Investigational Site Number :3800003	Catanzaro		Italy	88100
35	Investigational Site Number :3800002	Milano		Italy	20122
36	Investigational Site Number :4100002	Busan	Busan-gwangyeoksi	Korea, Republic of	49241
37	Investigational Site Number :4100003	Bucheon-si	Gyeonggi-do	Korea, Republic of	14584
38	Investigational Site Number :4100007	Incheon	Incheon-gwangyeoksi	Korea, Republic of	21431
39	Investigational Site Number :4100005	Seoul	Seoul-teukbyeolsi	Korea, Republic of	03722
40	Investigational Site Number :4100001	Seoul	Seoul-teukbyeolsi	Korea, Republic of	06973
41	Investigational Site Number :4100006	Seoul	Seoul-teukbyeolsi	Korea, Republic of	07441
42	Investigational Site Number :6200001	Coimbra		Portugal	3000-075
43	Investigational Site Number :6200002	Lisboa		Portugal	1998-018
44	Investigational Site Number :6200003	Porto		Portugal	4099-001
45	Investigational Site Number :7240008	Santullano	Asturias	Spain	33619
46	Investigational Site Number :7240009	Badalona	Barcelona [Barcelona]	Spain	08916
47	Investigational Site Number :7240001	Pontevedra	Galicia [Galicia]	Spain	36071
48	Investigational Site Number :7240004	Córdoba		Spain	14004
49	Investigational Site Number :7240007	Madrid		Spain	28034
50	Investigational Site Number :7240003	Valencia		Spain	46026
51	Investigational Site Number :7240002	Zaragoza		Spain	50009
52	Investigational Site Number :1580005	Hsinchu City		Taiwan	30059
53	Investigational Site Number :1580006	Kaohsiung		Taiwan	833
54	Investigational Site Number :1580008	Taichung		Taiwan
55	Investigational Site Number :1580001	Taipei		Taiwan	10002
56	Investigational Site Number :1580002	Taipei		Taiwan	10449
57	Investigational Site Number :8260001	Redhill	Surrey	United Kingdom	RH1 5RH

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: NCT04202679
• Other Study ID Numbers: EFC16460; 2019-003801-90; U1111-1241-8174
• First Posted: Dec 17, 2019
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 2, 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 Apr 25, 2022