Secukinumab open label roll-over extension protocol

• Register: EUCTR
• Last refreshed on: 3 February 2025
• Main ID: EUCTR2020-004284-98-BG
• Date of registration: 29/01/2021
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Secukinumab open label roll-over extension protocol
• Scientific title: An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment
• Date of first enrolment: 05/02/2021
• Target sample size: 776
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004284-98
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, Brazil, Bulgaria, China, Colombia, Czech Republic, Czechia, Greece, Guatemala, India, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Spain, Turkey, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent must be obtained for adult participants before any assessment is performed.Written informed assent and
parental permission (age as per local law) must be obtained for pediatric
participants before any assessment is performed. If participants reach
age of consent (age as per local law) during the study, they will need to
also sign the corresponding study informed consent(s).
2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
3. Participant has completed treatment per protocol in a Novartis study
of secukinumab (unless otherwise specified in a parent study protocol).
Participants, who derive benefit from the treatment with secukinumab
but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination
was due to reasons other than safety or lack of efficacy (technical /
administrative reasons).
4. Participant is deriving benefit from secukinumab, investigator believes
he/she would continue to derive benefit from secukinumab and the
benefit outweighs the risk, based on the investigator's judgement.
5. Participant is unable to obtain access to the marketed secukinumab
formulation per local prescription and/or reimbursement guidelines.
Are the trial subjects under 18? yes
Number of subjects for this age range: 49
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 453
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 274

Exclusion criteria:
1. Participant has Prematurely discontinued study treatment in the parent protocol for any reason.
2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).
Contraception methods include:
· Total abstinence, when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
· Female sterilization (have had surgical bilateral oophorectomy [with or without hysterectomy], total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
· Male sterilization (at least 6 months before taking study treatment). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
· Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository.
· Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF).Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms).Women are considered not of childbearing potential if they
are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.3.Use of prohibited medications.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis, moderate to severe chronic plaque psoriasis
MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

Main Objective: To evaluate long term safety as assessed by occurrence of AEs/SAEs

Timepoint(s) of evaluation of this end point: Over time up to EOS or Week116

Secondary Objective: Not applicable

Primary end point(s): Serious adverse events (SAEs), adverse events (AEs), and injection site reactions

Secondary Outcome(s)

Secondary end point(s): not applicable

Timepoint(s) of evaluation of this end point: not applicable

Secondary ID(s)

2020-004284-98-CZ

CAIN457A02001B

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 20/01/2021
Contact: