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Psoriatic ArthritisPhase 2/3NCT03552276

Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

A Phase 2/3 study testing SUNPG18_07 I (Tildrakizumab 200 mg) and SUNPG18_07 II (Tildrakizumab 100 mg) in people with Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 66 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
SUNPG18_07 I (Tildrakizumab 200 mg) and SUNPG18_07 II (Tildrakizumab 100 mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
66 sitesin 8 countries
Study dates
11 Jul 2018to 18 Sep 2023
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects may be included in the study if they meet all of the following criteria:
  • Subject has provided written informed consent for this long-term extension study.
  • Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
  • No concomitant use of both leflunomide and methotrexate,
  • No history of active tuberculosis (TB) or symptoms of TB.

Who cannot join

  • Subjects should be excluded from the study if they meet any of the following criteria:
  • New onset during the parent study of arthritic conditions other than the subject's original condition.
  • Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo-progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
  • Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
  • Subject has previously been enrolled in this long-term extension study.
  • Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
Show all 13Show fewer
  • Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
  • Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study.
  • Subjects with a history of alcohol or drug abuse during the parent study.
  • Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
  • Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for PsO and/or PsA
  • Subjects who have been placed in an institution on official or judicial orders.
  • Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.

Trial locations and contacts

66 sites in 8 countries.

66 sites in 8 countries

Poland14 sites

  • Site 38

    Bialystok, 15-879

  • Site 47

    Bytom, 41-902

  • Site 36

    Elblag, 82-300

  • Site 39

    Katowice, 40-081

  • Site 40

    Katowice, 40-282

  • Site 45

    Krakow, Lesser Poland Voivodeship, 30-510

  • Site 46

    Krakow, 30-002

  • Site 43

    Lodz, 90-265

  • Site 48

    Nowa Sól, 67-100

  • Site 42

    Poznan, 60-848

  • Site 53

    Sochaczew, 96-500

  • Site 50

    Warsaw, 02-691

  • Site 52

    Warsaw, 04-305

  • Site 51

    Wroclaw, 51-685

Other trials in Poland

United States13 sites

  • Site 19

    Cincinnati, Ohio, 45242

  • Site 14

    Denver, Colorado, 80230

  • Site 25

    Glendale, Arizona, 85306

  • Site 26

    Lebanon, New Hampshire, 03756

  • Site 23

    Lexington, Kentucky, 40504

  • Site 18

    Memphis, Tennessee, 38119

  • Site 17

    Middleburg Heights, Ohio, 44130

  • Site 20

    Monroe, Louisiana, 71203

  • Site 16

    Phoenix, Arizona, 85032

  • Site 24

    Salisbury, North Carolina, 28144

  • Site 21

    Seattle, Washington, 98122

  • Site 22

    Spokane, Washington, 99204

  • Site 27

    Wichita, Kansas, 67207

Other trials in United States

Mexico10 sites

  • Site 11

    Chihuahua City, 31000

  • Site 08

    Cuautitlán Izcalli, 54769

  • Site 07

    Culiacán, Sinaloa, 80000

  • Site 10

    Durango, 34080

  • Site 12

    Mérida, Yucatán, 97070

  • Site 09

    Mexico City, Mexico City, 06700

  • Site 05

    Mexico City, Mexico City, 7760

  • Site 06

    Monterrey, Nuevo León, 64020

  • Site 13

    San Luis Potosí City, San Luis Potosí, 78213

  • Site 04

    San Luis Potosí City, San Luis Potosí, 78220

Other trials in Mexico

Russia9 sites

  • Site 56

    Izhevsk, 426077

  • Site 61

    Kemerovo, Kemerovo Oblast, 650066

  • Site 60

    Moscow, 115404

  • Site 58

    Novosibirsk, Novosibirsk Oblast, 630099

  • Site 57

    Saint Petersburg, 196084

  • Site 62

    Smolensk, 214019

  • Site 54

    Tomsk, Tomsk Oblast, 634050

  • Site 55

    Yaroslavl, 150003

  • Site 59

    Yaroslavl, 150007

Other trials in Russia

Ukraine8 sites

  • Site 75

    Kharkiv, 61039

  • Site 73

    Kiev, 03151

  • Site 74

    Kyiv, 01023

  • Site 76

    Kyiv, 02091

  • Site 72

    Kyiv, 03110

  • Site 77

    Odesa, 65025

  • Site 79

    Vinnytsia, 21029

  • Site 78

    Zaporizhzhya, 69600

Other trials in Ukraine

Spain6 sites

  • Site 66

    Barcelona, 08034

  • Site 64

    Barcelona, 08035

  • Site 68

    Bilbao, Vizcaya, 48013

  • Site 65

    Málaga, Malaga, 29730

  • Site 67

    Santiago de Compostela, La Coruna, 15702

  • Site 71

    Seville, 41010

Other trials in Spain

Argentina3 sites

  • Site 02

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

  • Site 01

    Mar del Plata, Buenos Aires, 7600

  • Site 03

    San Fernando, Buenos Aires, 1646

Other trials in Argentina

Hungary3 sites

  • Site 32

    Budapest, 1036

  • Site 34

    Budapest, 1062

  • Site 33

    Kistarcsa, 2143

Other trials in Hungary

About this study

Official title: A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab

Read the detailed description

Subjects have rolled over from parent study, i.e., CLR_16_23, into the long-term extension study CLR_18_07.

The study has been open label post 1 year completion.

Being tested
SUNPG18_07 I (Tildrakizumab 200 mg), SUNPG18_07 II (Tildrakizumab 100 mg)
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUNPG18_07 I (Tildrakizumab 200 mg)Drug

    injection

  • SUNPG18_07 II (Tildrakizumab 100 mg)Drug

    injection

Study groups in NCT03552276
Study groupRoleWhat they receive
SUNPG18_07 q4 weeks, high doseExperimentalTildrakizumab 200 mg q4 Weeks
Receives: Drug: SUNPG18_07 I (Tildrakizumab 200 mg)
SUNPG18_07 q12 weeks, high doseExperimentalTildrakizumab 200 mg q12 Weeks
Receives: Drug: SUNPG18_07 I (Tildrakizumab 200 mg)
SUNPG18_07 q12 weeks, low doseExperimentalTildrakizumab 100 mg q12 Weeks
Receives: Drug: SUNPG18_07 II (Tildrakizumab 100 mg)
SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low DoseExperimentalTildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks
Receives: Drug: SUNPG18_07 I (Tildrakizumab 200 mg); Drug: SUNPG18_07 II (Tildrakizumab 100 mg)
SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low DoseExperimentalTildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks
Receives: Drug: SUNPG18_07 I (Tildrakizumab 200 mg); Drug: SUNPG18_07 II (Tildrakizumab 100 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

    Please refer to Adverse event section for more information

    Measured: upto week 208

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start11 Jul 2018
  3. Primary completion18 Sep 2023
  4. Study completion18 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552276
Sponsor's protocol ID
CLR_18_07
Status last verified
Oct 2024
First submitted
4 May 2018
Last updated
21 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SUNPG18_07 I (Tildrakizumab 200 mg) and SUNPG18_07 II (Tildrakizumab 100 mg) in people with Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 66 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Poland, United States, Mexico, Russia, Ukraine and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: upto week 208). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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