Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03827798
• Collaborator: (none)
• Enrollment: 200
• Locations: 40
• Arms: 9
• Anticipated Duration (Months): 51.6
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 and LOU064 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825 and LOU064 have an adequate clinical profile for further clinical development.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Drug: CFZ533; Drug: Placebo to CFZ533; Drug: LYS006; Drug: Placebo to LYS006; Drug: MAS825; Drug: Placebo to MAS825; Drug: LOU064 25mg; Drug: LOU064 100mg; Drug: Placebo to LOU064	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa
• Actual Study Start Date: Feb 27, 2019
• Anticipated Primary Completion Date: Aug 22, 2022
• Anticipated Study Completion Date: Jun 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CFZ533 s.c.	Drug: CFZ533; s.c.
Experimental: LYS006 p.o.	Drug: LYS006; p.o.
Placebo Comparator: Placebo to CFZ533 Matching placebo (s.c.)	Drug: Placebo to CFZ533; s.c.
Placebo Comparator: Placebo to LYS006 Matching placebo (p.o.)	Drug: Placebo to LYS006; p.o.
Experimental: MAS825 s.c.	Drug: MAS825; s.c.
Placebo Comparator: Placebo to MAS825 Matching placebo (s.c.)	Drug: Placebo to MAS825; s.c.
Active Comparator: LOU064 25mg p.o.	Drug: LOU064 25mg; p.o.
Active Comparator: LOU064 100mg p.o.	Drug: LOU064 100mg; p.o.
Placebo Comparator: Placebo to LOU064 Matching placebo p.o.	Drug: Placebo to LOU064; p.o.

Outcome Measures

Primary Outcome Measures

1. Hidradenitis Suppurativa Clinical Response (HiSCR) [16 weeks]

   Proportion of patients achieving clinical response after 16 weeks of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved

• Minimal body weight of 50 kg

• Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule

Exclusion Criteria:

• Use of other investigational drugs at the time of screening or before

• Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

• Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Orange Park	Florida	United States	32073
2	Novartis Investigative Site	Tampa	Florida	United States	33609
3	Novartis Investigative Site	Tampa	Florida	United States	33612
4	Novartis Investigative Site	Sandy Springs	Georgia	United States	30328
5	Novartis Investigative Site	Evanston	Illinois	United States	60201
6	Novartis Investigative Site	Indianapolis	Indiana	United States	46256
7	Novartis Investigative Site	Boston	Massachusetts	United States	02215
8	Novartis Investigative Site	Omaha	Nebraska	United States	68144
9	Novartis Investigative Site	Hershey	Pennsylvania	United States	17033-0850
10	Novartis Investigative Site	Charleston	South Carolina	United States	29425
11	Novartis Investigative Site	Graz		Austria	8036
12	Novartis Investigative Site	Wien		Austria	A 1090
13	Novartis Investigative Site	Bruxelles		Belgium	1070
14	Novartis Investigative Site	Prague	Prague 1	Czechia	11000
15	Novartis Investigative Site	Copenhagen NV		Denmark	2400
16	Novartis Investigative Site	Roskilde		Denmark	4000
17	Novartis Investigative Site	Lyon		France	69437
18	Novartis Investigative Site	Marseille Cedex 05		France	13885
19	Novartis Investigative Site	Nice Cedex		France	06202
20	Novartis Investigative Site	Rouen Cedex		France	76031
21	Novartis Investigative Site	Bochum		Germany	44791
22	Novartis Investigative Site	Darmstadt		Germany	64297
23	Novartis Investigative Site	Frankfurt		Germany	60590
24	Novartis Investigative Site	Halle (Saale)		Germany	06108
25	Novartis Investigative Site	Koeln		Germany	50937
26	Novartis Investigative Site	Schwerin		Germany	19055
27	Novartis Investigative Site	Budapest		Hungary	1085
28	Novartis Investigative Site	Debrecen		Hungary	4032
29	Novartis Investigative Site	Pecs		Hungary	7623
30	Novartis Investigative Site	Szeged		Hungary	H 6725
31	Novartis Investigative Site	Kopavogur		Iceland	201
32	Novartis Investigative Site	Groningen		Netherlands	9713 GZ
33	Novartis Investigative Site	Rotterdam		Netherlands	3015 CE
34	Novartis Investigative Site	Sabadell	Barcelona	Spain	08208
35	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46026
36	Novartis Investigative Site	Manises	Valencia	Spain	46940
37	Novartis Investigative Site	Barcelona		Spain	08041
38	Novartis Investigative Site	Granada		Spain	18012
39	Novartis Investigative Site	Las Palmas de Gran Canaria		Spain	35010
40	Novartis Investigative Site	Madrid		Spain	28031

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03827798
• Other Study ID Numbers: CCFZ533H12201BC
• First Posted: Feb 1, 2019
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Hidradenitis suppurativa, acne inversa, platform study
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Antibodies, Monoclonal

Study Results

No Results Posted as of Aug 24, 2022