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Recurrent Pregnancy LossPhase 2RESPONSENCT02156063

A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

A Phase 2 study testing NT100 in people with Recurrent Pregnancy Loss and Recurrent Miscarriage, run by Nora Therapeutics, Inc. at 19 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo. Read more about this study

Who is it for?
Ages 18 to 37 years, women only
What is being tested?
NT100
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
19 sitesUnited Kingdom
Study dates
Jun 2014to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pre-menopausal female 18-37 years of age at consent, trying to conceive
  • Documented history of unexplained recurrent pregnancy loss
  • Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
  • Body mass index (BMI) of 19-35 kg/m2 at consent

Who cannot join

  • Greater than 5 weeks of gestation when presenting for randomisation.
  • Known karyotype abnormalities in either the participant or her current male partner
  • Uncorrected clinically significant intrauterine abnormalities
  • Abnormal vaginal bleeding of unknown cause
  • Current diagnosis of infertility in either the participant or her current male partner
  • Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
  • Any uncontrolled clinically significant medical condition

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United Kingdom19 sites

  • Study site

    Ashington

  • Study site

    Birmingham

  • Study site

    Chertsey, Surrey

  • Study site

    Coventry

  • Study site

    Edinburgh

  • Study site

    Frimley, Surrey

  • Study site

    Leeds

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Middlesbrough

  • Study site

    Newcastle upon Tyne

  • Study site

    Nottingham

  • Study site

    Oxford

  • Study site

    Plymouth

  • Study site

    South Shields

  • Study site

    Southamptom

  • Study site

    Stoke-on-Trent

  • Study site

    Sunderland

Other trials in United Kingdom

About this study

Official title: A Randomised, Double Blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.

Read the detailed description

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo. Participants will be screened for eligibility, and will begin attempts at spontaneous conception. Following randomization and initiation of study drug treatment, participants will visit the study site at specified intervals throughout the study for assessments and blood work.

All participants will be monitored for adverse events. All participants who have received at least one dose of study drug will be followed for safety for a minimum of 4 weeks following the last dose of study drug. After delivery, pregnancy outcome information will be obtained.

Being tested
NT100, Placebo
Keywords
Recurrent Pregnancy Loss, Recurrent Miscarriage, Miscarriage, Pregnancy Loss, Repeated Pregnancy Loss
Medical subject headings
Abortion, Habitual, Abortion, Spontaneous

What participants receive

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

  • NT100Drug

  • PlaceboDrug

Study groups in NCT02156063
Study groupRoleWhat they receive
NT100ExperimentalNT100 Dose 1
Receives: Drug: NT100
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Clinical Pregnancy

    The primary outcome measure is clinical pregnancy at Week 20 of gestation

    Measured: at Week 20 of gestation

Secondary outcomes (6)

  1. Live birth

    Measured: at any time during pregnancy

  2. Clinical pregnancy

    Measured: at Weeks 6, 8 and 12 of gestation

  3. Spontaneous pregnancy loss

    Measured: within 24 weeks of gestation

  4. Stillbirth

    Measured: after 24 weeks of gestation

  5. Subjects with adverse events and serious adverse events

    Measured: during treatment and within 4 weeks after treatment

  6. Changes in clinical laboratory parameters following study drug exposure

    Measured: during treatment and within 4 weeks after treatment

Timeline

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

  1. First posted5 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2016 (estimated)
  4. Study completionJun 2016 (estimated)

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156063
Sponsor's protocol ID
NT-05
Acronym
RESPONSE
Status last verified
Jul 2015
First submitted
3 Jun 2014
Last updated
15 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Eapen A, Joing M, Kwon P, Tong J, Maneta E, De Santo C, Mussai F, Lissauer D, Carter D; RESPONSE study group. Recombinant human granulocyte- colony stimulating factor in women with unexplained recurrent pregnancy losses: a randomized clinical trial. Hum Reprod. 2019 Mar 1;34(3):424-432. doi: 10.1093/humrep/dey393.

    PubMed 30776296

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NT100 in people with Recurrent Pregnancy Loss and Recurrent Miscarriage, run by Nora Therapeutics, Inc. at 19 sites in United Kingdom.

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 7 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: status not confirmed, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom. 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?

Results are not available in the source record.

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?

Clinical Pregnancy (time frame: at Week 20 of gestation). 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 NCT02156063, 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 15 Jul 2015.

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