Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisPhase 2NCT02980705
Efficacy and Safety Study of SUNPG1622
A Phase 2 study testing SUNPG1622 I dose in people with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis, run by Sun Pharmaceutical Industries Limited at 4 sites in 4 countries.
Trial summary
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
- What is being tested?
- SUNPG1622 I dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 6 Nov 2017to 3 Sep 2019
- Phase
- Phase 2
- 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
- Subject has provided informed written consent
- Subject is ≥ 18 years of age at time of Screening
- Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
- Subject has a negative test for TB within 4 weeks before initiating IMP
Who cannot join
- Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
- Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
- Radiographic evidence of total ankylosis of the spine
- Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
- Being tested
- SUNPG1622 I dose, Placebo dose
- Medical subject headings
- Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUNPG1622 I doseDrug
Injection
Placebo doseDrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| SUNPG1622 I | Experimental | SUNPG1622 I dose Receives: Drug: SUNPG1622 I dose |
| Placebo | Placebo comparator | Placebo dose Receives: Drug: Placebo dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of SpondyloArthritis International Society 20 Response Rates
Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).
Measured: Week 24
Secondary outcomes (1)
Assessment of SpondyloArthritis International Society 20 Response Rates
Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.
Measured: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start6 Nov 2017
- Primary completion21 Feb 2019
- Study completion3 Sep 2019
Why it stopped: Study terminated-Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980705
- Sponsor's protocol ID
- CLR_16_22
- Status last verified
- Oct 2021
- First submitted
- 30 Nov 2016
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. J Clin Rheumatol. 2023 Aug 1;29(5):223-229. doi: 10.1097/RHU.0000000000001973. Epub 2023 May 10.
PubMed 37162744
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT02980705
- Acronym / sponsor ID
- CLR_16_22
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated-Sponsor's decision
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUNPG1622 I | Experimental | Drug: SUNPG1622 I doseSUNPG1622 I dose |
| Placebo | Placebo comparator | Drug: Placebo dosePlacebo dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has provided informed written consent
- Subject is ≥ 18 years of age at time of Screening
- Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
- Subject has a negative test for TB within 4 weeks before initiating IMP
Key exclusion criteria (4 listed)
- Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
- Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
- Radiographic evidence of total ankylosis of the spine
- Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUNPG1622 I doseInjection | Drug | SUNPG1622 I |
| Placebo doseInjection | Drug | Placebo |
Primary outcome
Assessment of SpondyloArthritis International Society 20 Response Rates
Time frame: Week 24
Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).
1 secondary outcome
Assessment of SpondyloArthritis International Society 20 Response Rates
Time frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37162744Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. J Clin Rheumatol. 2023 Aug 1;29(5):223-229. doi: 10.1097/RHU.0000000000001973. Epub 2023 May 10.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUNPG1622 I dose in people with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis, run by Sun Pharmaceutical Industries Limited at 4 sites in 4 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Hungary, Poland, Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Feb 2021). 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?
Assessment of SpondyloArthritis International Society 20 Response Rates (time frame: Week 24). 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 NCT02980705, which also lists 1 linked publication.
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 1 Nov 2021.