A MULTI-CENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY FOLLOWED BY AN EXTENSION PERIOD EVALUATING THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-044-16
• Date of registration: 13/03/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL,
• Public title: A MULTI-CENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY FOLLOWED BY AN EXTENSION PERIOD EVALUATING THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
• Scientific title: A MULTI-CENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY FOLLOWED BY AN EXTENSION PERIOD EVALUATING THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
• Date of first enrolment: 05/05/2017
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=044-16
• Study type: Interventional
• Study design: SL0023 is a 2-part study consisting of a randomized, double-blind, PBO-controlled,; parallel-group, dose-ranging period (24-week Double-Blind Treatment Period; Part 1) followed; by a 24-week Observational Period (Part 2) in adult subjects with moderately to severely active; SLE who are receiving stable standard-of-care medications (ie, corticosteroids,; immunosuppressants, and/or antimalarials) at study entry.; The study consists of a Screening Period of up to 4 weeks, a 24-week Double-Blind Treatment; Period (Part 1), and a 24-week Observational Period (Part 2).
• Phase: II

Countries of recruitment

Argentina, Bulgaria, Chile, Colombia, Germany, Mexico, Peru, Russian Federation, Spain, United States

Contacts

• Name: Narda Lozada Malpartida
• Affiliation: SYNEOS HEALTH PERU S.R.L.

• Name: Narda Lozada Malpartida
• Affiliation: SYNEOS HEALTH PERU S.R.L.

Key inclusion & exclusion criteria

Inclusion criteria:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written
Informed Consent form is signed and dated by the subject or legal representative prior to the
initiation of any study-specific assessment at Screening (Visit 1).
2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand
and complete diaries), visit schedule, and medication intake according to the judgment of the
Investigator.
3. Subject (male or female) is ≥18 years of age at Screening (Visit 1).
4. Subject has a bodyweight of ≥50kg and ≤160kg.
5. Adequate reading and writing abilities (in native language) such that the subject can
comprehend and answer the questions on the subject completed assessments.
6. The subject has SLE diagnosed by a physician, confirmed by the SLICC Classification
Criteria for SLE.
The subject has moderate to severe SLE disease activity as demonstrated by BILAG 2004

Exclusion criteria:
1. Subject has previously been randomized in this study or has previously participated in a DZP
clinical study.
2. Subject has any medical or psychiatric condition that, in the opinion of the Investigator,
could jeopardize or would compromise the subject’s ability to participate in this study.
3. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
study or within 3 months following their final dose of study drug.
4. Subject has a history of malignancy, except the following treated cancers: cervical carcinoma
in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
5. Subject has a mixed connective tissue disease, scleroderma, and/or overlap syndromes of
SLE.
Subjects with SLE and secondary Sjögren’s syndrome are permitted provided they meet
the eligibility criteria. ETC


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

-M32 Systemic lupus erythematosus
Systemic lupus erythematosus

M32

Systemic lupus erythematosus

Intervention(s)

Study drug will be administered by iv infusion every 4 weeks during Part 1 of the
study. Subjects who withdraw early from the 24-week Double-Blind Treatment Period (Part 1)
will enter an 8-week SFU Period (which ends 12 weeks after the final dose of study drug).

Source(s) of Monetary Support

UCB Biopharma SPRL

Ethics review

Status: Approved
Approval date: 22/09/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 24/11/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 11/01/2017
Contact:

[e-mail]

Hospital Nacional Edgardo Rebagliati Martins

2654901-3080 2640516

[e-mail]

Results

• Results available: Yes
• Date Completed: 14/11/2018