Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03827798 |
Recruitment Status :
Recruiting
First Posted : February 1, 2019
Last Update Posted : April 26, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Drug: VAY736 Drug: Placebo to VAY736 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 245 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 : | February 27, 2019 |
Estimated Primary Completion Date : | November 22, 2024 |
Estimated Study Completion Date : | October 23, 2026 |
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
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. |
Experimental: VAY736
s.c.
|
Drug: VAY736
s.c. |
Placebo Comparator: Placebo to VAY736
Matching placebo (s.c.)
|
Drug: Placebo to VAY736
s.c. |
- simplified Hidradenitis Suppurativa Clinical Response (sHiSCR) [ Time Frame: 16 weeks ]Proportion of patients achieving clinical response after 16 weeks of treatment
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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
![](/ct2/html/images/NIH_NLM_ABRV_BLK_4.png)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827798
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |
![Show](/ct2/html/images/expand.png)
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03827798 |
Other Study ID Numbers: |
CCFZ533H12201BC |
First Posted: | February 1, 2019 Key Record Dates |
Last Update Posted: | April 26, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hidradenitis suppurativa, acne inversa, platform study |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses |
Infections Skin Diseases, Infectious Suppuration Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |